Trial Outcomes & Findings for A Study Evaluating Platinum-Pemetrexed-Atezolizumab (+/-Bevacizumab) for Patients With Stage IIIB/IV Non-squamous Non-small Cell Lung Cancer With EGFR Mutations, ALK Rearrangement or ROS1 Fusion Progressing After Targeted Therapies (NCT NCT04042558)

NCT ID: NCT04042558

Last Updated: 2026-05-12

Results Overview

The objective response rate (ORR) is defined as the percentage of patients who achieved an objective response after 4 cycles of induction treatment (or before progression). Objective response will be considered in case of radiologically confirmed complete (CR) or partial response (PR) according to RECIST v 1.1 criteria (Response Evaluation Criteria in Solid Tumors version 1.1) by the masked, independent central board. Per RECIST v1.0, for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Patients not meeting these criteria, including patients without any post-baseline tumour assessment, will be considered non-responders. The confirmation of response in accordance with RECIST v.1.1 is not required, but ORR with confirmation may be evaluated as an exploratory endpoint.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

150 participants

Primary outcome timeframe

After the end of 4 cycles (15 weeks)

Results posted on

2026-05-12

Participant Flow

A total of 168 patients were screened from September 2019 to October 2021 in 27 centres and 149 were included : 71 in the cohort with bevacizumab (PPAB cohort) and 78 in the cohort without bevacizumab (PPA cohort).

Participant milestones

Participant milestones
Measure
Cohort With Bevacizumab
4 cycles of induction every 3 weeks with : * Carboplatin area under curve 6 mg/mL per minute per IV route or Cisplatin 75 mg/m² per IV route * Pemetrexed 500 mg/m² per IV route * Atezolizumab 1200 mg per IV route * Bevacizumab 15 mg/kg per IV route For patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed and Bevacizumab administered at the same dosage on 3-week cycles
Cohort Without Bevacizumab
4 cycles of induction every 3 weeks with : * Carboplatin area under curve 6 mg/mL per minute per IV route or Cisplatin 75 mg/m² per IV route * Pemetrexed 500 mg/m² per IV route * Atezolizumab 1200 mg per IV route For patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed administered at the same dosage on 3-week cycles
Overall Study
STARTED
71
78
Overall Study
COMPLETED
67
71
Overall Study
NOT COMPLETED
4
7

Reasons for withdrawal

Reasons for withdrawal
Measure
Cohort With Bevacizumab
4 cycles of induction every 3 weeks with : * Carboplatin area under curve 6 mg/mL per minute per IV route or Cisplatin 75 mg/m² per IV route * Pemetrexed 500 mg/m² per IV route * Atezolizumab 1200 mg per IV route * Bevacizumab 15 mg/kg per IV route For patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed and Bevacizumab administered at the same dosage on 3-week cycles
Cohort Without Bevacizumab
4 cycles of induction every 3 weeks with : * Carboplatin area under curve 6 mg/mL per minute per IV route or Cisplatin 75 mg/m² per IV route * Pemetrexed 500 mg/m² per IV route * Atezolizumab 1200 mg per IV route For patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed administered at the same dosage on 3-week cycles
Overall Study
Eligibility criteria not met
3
5
Overall Study
Protocol Violation
1
1
Overall Study
Absence of target lesion
0
1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cohort With Bevacizumab
n=71 Participants
4 cycles of induction every 3 weeks with : * Carboplatin area under curve 6 mg/mL per minute per IV route or Cisplatin 75 mg/m² per IV route * Pemetrexed 500 mg/m² per IV route * Atezolizumab 1200 mg per IV route * Bevacizumab 15 mg/kg per IV route For patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed and Bevacizumab administered at the same dosage on 3-week cycles
Cohort Without Bevacizumab
n=78 Participants
4 cycles of induction every 3 weeks with : * Carboplatin area under curve 6 mg/mL per minute per IV route or Cisplatin 75 mg/m² per IV route * Pemetrexed 500 mg/m² per IV route * Atezolizumab 1200 mg per IV route For patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed administered at the same dosage on 3-week cycles
Total
n=149 Participants
Total of all reporting groups
Age, Continuous
60.4 years
STANDARD_DEVIATION 10.2 • n=71 Participants
66.1 years
STANDARD_DEVIATION 10.2 • n=78 Participants
63.4 years
STANDARD_DEVIATION 10.2 • n=149 Participants
Sex: Female, Male
Female
49 Participants
n=71 Participants
40 Participants
n=78 Participants
89 Participants
n=149 Participants
Sex: Female, Male
Male
22 Participants
n=71 Participants
38 Participants
n=78 Participants
60 Participants
n=149 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: After the end of 4 cycles (15 weeks)

Population: 3 eligibility criteria not met and 1 not treated according to protocol in the cohort with bevacizumab. 5 eligibility criteria not met, 1 not treated according to protocol and 1 with absence of target lesion in the cohort without bevacizumab

The objective response rate (ORR) is defined as the percentage of patients who achieved an objective response after 4 cycles of induction treatment (or before progression). Objective response will be considered in case of radiologically confirmed complete (CR) or partial response (PR) according to RECIST v 1.1 criteria (Response Evaluation Criteria in Solid Tumors version 1.1) by the masked, independent central board. Per RECIST v1.0, for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Patients not meeting these criteria, including patients without any post-baseline tumour assessment, will be considered non-responders. The confirmation of response in accordance with RECIST v.1.1 is not required, but ORR with confirmation may be evaluated as an exploratory endpoint.

Outcome measures

Outcome measures
Measure
Cohort With Bevacizumab
n=67 Participants
4 cycles of induction every 3 weeks with : * Carboplatin area under curve 6 mg/mL per minute per IV route or Cisplatin 75 mg/m² per IV route * Pemetrexed 500 mg/m² per IV route * Atezolizumab 1200 mg per IV route * Bevacizumab 15 mg/kg per IV route For patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed and Bevacizumab administered at the same dosage on 3-week cycles
Cohort Without Bevacizumab
n=71 Participants
4 cycles of induction every 3 weeks with : * Carboplatin area under curve 6 mg/mL per minute per IV route or Cisplatin 75 mg/m² per IV route * Pemetrexed 500 mg/m² per IV route * Atezolizumab 1200 mg per IV route For patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed administered at the same dosage on 3-week cycles
Objective Response Rate (ORR) According to RECIST 1.1
39 Participants
33 Participants

SECONDARY outcome

Timeframe: 1 year

PFS is defined as the time relapsed between inclusion and disease progression (according to RECIST v1.1 criteria as assessed by the investigator) or death from any cause, whichever occurs first. Patients who have not progressed and who have not died at the time of analysis will be censored at the time of last tumour assessment date. If no tumour assessments were performed after the date of the first occurrence of a CR or PR, PFS will be censored at the date of the first occurrence of a CR or PR plus 1 day. Progression is defined according to Response Evaluation Criteria In Solid Tumors (RECIST v1.1) as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum recorded on study, with an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure
Cohort With Bevacizumab
n=67 Participants
4 cycles of induction every 3 weeks with : * Carboplatin area under curve 6 mg/mL per minute per IV route or Cisplatin 75 mg/m² per IV route * Pemetrexed 500 mg/m² per IV route * Atezolizumab 1200 mg per IV route * Bevacizumab 15 mg/kg per IV route For patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed and Bevacizumab administered at the same dosage on 3-week cycles
Cohort Without Bevacizumab
n=71 Participants
4 cycles of induction every 3 weeks with : * Carboplatin area under curve 6 mg/mL per minute per IV route or Cisplatin 75 mg/m² per IV route * Pemetrexed 500 mg/m² per IV route * Atezolizumab 1200 mg per IV route For patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed administered at the same dosage on 3-week cycles
The Progression-free Survival (PFS)
7.3 month
Interval 6.9 to 9.0
7.2 month
Interval 5.7 to 9.2

SECONDARY outcome

Timeframe: 2 years

OS is defined as the time between the date of inclusion and death from any cause. Patients who are not reported as having died at the date of analysis will be censored at the date when they were last known to be alive. Patients who do not have post-baseline information will be censored at the date of inclusion plus 1 day.

Outcome measures

Outcome measures
Measure
Cohort With Bevacizumab
n=67 Participants
4 cycles of induction every 3 weeks with : * Carboplatin area under curve 6 mg/mL per minute per IV route or Cisplatin 75 mg/m² per IV route * Pemetrexed 500 mg/m² per IV route * Atezolizumab 1200 mg per IV route * Bevacizumab 15 mg/kg per IV route For patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed and Bevacizumab administered at the same dosage on 3-week cycles
Cohort Without Bevacizumab
n=71 Participants
4 cycles of induction every 3 weeks with : * Carboplatin area under curve 6 mg/mL per minute per IV route or Cisplatin 75 mg/m² per IV route * Pemetrexed 500 mg/m² per IV route * Atezolizumab 1200 mg per IV route For patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed administered at the same dosage on 3-week cycles
The Overall Survival
17.2 month
Interval 13.7 to
Not enough events to estimate upper bound of 95% confidence interval
16.8 month
Interval 13.5 to
Not enough events to estimate upper bound of 95% confidence interval

SECONDARY outcome

Timeframe: 1 year

Population: 39 of the 67 patients of the Cohort with Bevacizumab group observed response during the study, and 33 of the 71 patients of the Cohort without Bevacizumab.

Duration of response will be assessed in patients who had an objective response (CR or PR) as determined by the investigator using RECIST v1.1. DOR is defined as the time interval from the date of the first occurrence of a CR or PR (whichever status is recorded first) until the first date that progressive disease or death is documented, whichever occurs first. Patients who have not progressed and who have not died at the time of analysis will be censored at the time of last tumour assessment date. If no tumour assessments were performed after the date of the first occurrence of a CR or PR, DOR will be censored at the date of the first occurrence of a CR or PR plus 1 day.

Outcome measures

Outcome measures
Measure
Cohort With Bevacizumab
n=39 Participants
4 cycles of induction every 3 weeks with : * Carboplatin area under curve 6 mg/mL per minute per IV route or Cisplatin 75 mg/m² per IV route * Pemetrexed 500 mg/m² per IV route * Atezolizumab 1200 mg per IV route * Bevacizumab 15 mg/kg per IV route For patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed and Bevacizumab administered at the same dosage on 3-week cycles
Cohort Without Bevacizumab
n=33 Participants
4 cycles of induction every 3 weeks with : * Carboplatin area under curve 6 mg/mL per minute per IV route or Cisplatin 75 mg/m² per IV route * Pemetrexed 500 mg/m² per IV route * Atezolizumab 1200 mg per IV route For patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed administered at the same dosage on 3-week cycles
The Duration of Response
6.25 month
Standard Deviation 3.7
4.60 month
Standard Deviation 3.8

Adverse Events

Cohort With Bevacizumab

Serious events: 33 serious events
Other events: 68 other events
Deaths: 6 deaths

Cohort Without Bevacizumab

Serious events: 29 serious events
Other events: 65 other events
Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure
Cohort With Bevacizumab
n=68 participants at risk
4 cycles of induction every 3 weeks with : * Carboplatin area under curve 6 mg/mL per minute per IV route or Cisplatin 75 mg/m² per IV route * Pemetrexed 500 mg/m² per IV route * Atezolizumab 1200 mg per IV route * Bevacizumab 15 mg/kg per IV route For patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed and Bevacizumab administered at the same dosage on 3-week cycles Carboplatin + Pemetrexed + Atezolizumab + Bevacizumab: 4 cycles of induction every 3 weeks of cisplatine,pemetrexed, atezolizumab + bevacizumab and patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed +/- Bevacizumab administered at the same dosage on 3-week cycles
Cohort Without Bevacizumab
n=72 participants at risk
4 cycles of induction every 3 weeks with : * Carboplatin area under curve 6 mg/mL per minute per IV route or Cisplatin 75 mg/m² per IV route * Pemetrexed 500 mg/m² per IV route * Atezolizumab 1200 mg per IV route For patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed administered at the same dosage on 3-week cycles Carboplatin + Pemetrexed + Atezolizumab: Carboplatin + Pemetrexed + Atezolizumab
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PULMONARY EMBOLISM
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
5.6%
4/72 • Number of events 4 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
BLOOD AND LYMPHATIC SYSTEM DISORDERS
PANCYTOPENIA
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PYREXIA
8.8%
6/68 • Number of events 6 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
4.2%
3/72 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
VARICELLA ZOSTER VIRUS INFECTION
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
EYE DISORDERS
CORNEAL ENDOTHELIITIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
DYSPHAGIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
ENCEPHALOPATHY
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
STOMATITIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
BLOOD AND LYMPHATIC SYSTEM DISORDERS
FEBRILE NEUTROPENIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
DYSPNOEA
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
4.2%
3/72 • Number of events 4 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
ARTHRALGIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
HAEMOPTYSIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PNEUMONITIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
VASCULAR DISORDERS
HYPERTENSION
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
HEPATOBILIARY DISORDERS
HEPATITIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
CHEST PAIN
1.5%
1/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PLEURAL EFFUSION
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
BLOOD AND LYMPHATIC SYSTEM DISORDERS
ANAEMIA
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
4.2%
3/72 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
HEPATOBILIARY DISORDERS
HEPATIC CYTOLYSIS
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
HEPATOBILIARY DISORDERS
CHOLESTASIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
OSTEONECROSIS OF JAW
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
METASTASES TO PERITONEUM
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
INTESTINAL OBSTRUCTION
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
HEADACHE
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
METASTASES TO MENINGES
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
ENDOCRINE DISORDERS
HYPERTHYROIDISM
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
NAUSEA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
VOMITING
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
GENERAL PHYSICAL HEALTH DETERIORATION
7.4%
5/68 • Number of events 5 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
ASTHENIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RENAL AND URINARY DISORDERS
ACUTE KIDNEY INJURY
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
SUDDEN DEATH
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
BLOOD AND LYMPHATIC SYSTEM DISORDERS
FEBRILE BONE MARROW APLASIA
4.4%
3/68 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
SPINAL CORD COMPRESSION
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
BLOOD AND LYMPHATIC SYSTEM DISORDERS
THROMBOCYTOPENIA
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
4.2%
3/72 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
WEIGHT DECREASED
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
HYDROCEPHALUS
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
ISCHAEMIC CEREBRAL INFARCTION
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
COVID-19
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
FATIGUE
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
METABOLISM AND NUTRITION DISORDERS
DEHYDRATION
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RENAL AND URINARY DISORDERS
RENAL FAILURE
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
ISCHAEMIC STROKE
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
BLOOD AND LYMPHATIC SYSTEM DISORDERS
IRON DEFICIENCY ANAEMIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RENAL AND URINARY DISORDERS
CHRONIC KIDNEY DISEASE
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
METABOLISM AND NUTRITION DISORDERS
HYPERCALCAEMIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
EPILEPSY
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
CANCER PAIN
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PLEURISY
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
CARDIAC DISORDERS
PERICARDIAL EFFUSION
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
CARDIAC DISORDERS
IMMUNE-MEDIATED MYOCARDITIS
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
BLOOD AND LYMPHATIC SYSTEM DISORDERS
BONE MARROW FAILURE
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
LUNG DISORDER
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
CENTRAL NERVOUS SYSTEM LESION
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
VASCULAR DISORDERS
DEEP VEIN THROMBOSIS
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
PRODUCT ISSUES
DEVICE DISLOCATION
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
MEDICATION ERROR
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
POSTOPERATIVE WOUND INFECTION
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SURGICAL AND MEDICAL PROCEDURES
THORACIC CAVITY DRAINAGE
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
RESPIRATORY DISTRESS
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
BLOOD AND LYMPHATIC SYSTEM DISORDERS
NEUTROPENIA
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
CARDIAC DISORDERS
VENTRICULAR TACHYCARDIA
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
CARDIAC DISORDERS
CONGESTIVE CARDIOMYOPATHY
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
SEPSIS
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
EYE DISORDERS
OPTIC ATROPHY
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
OBSTRUCTION
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
SEPTIC SHOCK
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
SKIN DISORDER
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
PSYCHIATRIC DISORDERS
DEPRESSION
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
FEMUR FRACTURE
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
VASCULAR DISORDERS
JUGULAR VEIN THROMBOSIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
RECTAL HAEMORRHAGE
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
CARDIAC DISORDERS
MYOCARDITIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
METABOLISM AND NUTRITION DISORDERS
HYPONATRAEMIA
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
CARDIAC DISORDERS
TACHYCARDIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
APPENDICITIS PERFORATED
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
HEMIPARESIS
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.

Other adverse events

Other adverse events
Measure
Cohort With Bevacizumab
n=68 participants at risk
4 cycles of induction every 3 weeks with : * Carboplatin area under curve 6 mg/mL per minute per IV route or Cisplatin 75 mg/m² per IV route * Pemetrexed 500 mg/m² per IV route * Atezolizumab 1200 mg per IV route * Bevacizumab 15 mg/kg per IV route For patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed and Bevacizumab administered at the same dosage on 3-week cycles Carboplatin + Pemetrexed + Atezolizumab + Bevacizumab: 4 cycles of induction every 3 weeks of cisplatine,pemetrexed, atezolizumab + bevacizumab and patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed +/- Bevacizumab administered at the same dosage on 3-week cycles
Cohort Without Bevacizumab
n=72 participants at risk
4 cycles of induction every 3 weeks with : * Carboplatin area under curve 6 mg/mL per minute per IV route or Cisplatin 75 mg/m² per IV route * Pemetrexed 500 mg/m² per IV route * Atezolizumab 1200 mg per IV route For patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed administered at the same dosage on 3-week cycles Carboplatin + Pemetrexed + Atezolizumab: Carboplatin + Pemetrexed + Atezolizumab
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PYREXIA
11.8%
8/68 • Number of events 8 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
5.6%
4/72 • Number of events 7 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
NIGHT SWEATS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MUSCLE SPASMS
4.4%
3/68 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
PARONYCHIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
HAEMORRHOIDS
7.4%
5/68 • Number of events 5 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
CATHETER SITE PAIN
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
BLOOD AND LYMPHATIC SYSTEM DISORDERS
ANAEMIA
41.2%
28/68 • Number of events 35 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
51.4%
37/72 • Number of events 45 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
BLOOD AND LYMPHATIC SYSTEM DISORDERS
NEUTROPENIA
26.5%
18/68 • Number of events 21 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
27.8%
20/72 • Number of events 33 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
BLOOD AND LYMPHATIC SYSTEM DISORDERS
THROMBOCYTOPENIA
14.7%
10/68 • Number of events 10 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
13.9%
10/72 • Number of events 19 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
HEPATOBILIARY DISORDERS
HEPATOTOXICITY
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
CONJUNCTIVITIS
8.8%
6/68 • Number of events 10 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
5.6%
4/72 • Number of events 4 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RENAL AND URINARY DISORDERS
NEPHROPATHY TOXIC
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RENAL AND URINARY DISORDERS
PROTEINURIA
8.8%
6/68 • Number of events 6 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
PRODUCT ISSUES
INTERNAL DEVICE EXPOSED
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
FATIGUE
23.5%
16/68 • Number of events 28 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
11.1%
8/72 • Number of events 9 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
ENDOCRINE DISORDERS
HYPOTHYROIDISM
7.4%
5/68 • Number of events 5 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
URINARY TRACT INFECTION
5.9%
4/68 • Number of events 7 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
HEADACHE
20.6%
14/68 • Number of events 17 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
9.7%
7/72 • Number of events 11 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
NAUSEA
58.8%
40/68 • Number of events 60 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
41.7%
30/72 • Number of events 43 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
EYE DISORDERS
LACRIMATION INCREASED
10.3%
7/68 • Number of events 9 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
9.7%
7/72 • Number of events 8 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
CYSTITIS
4.4%
3/68 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
METABOLISM AND NUTRITION DISORDERS
HYPOMAGNESAEMIA
5.9%
4/68 • Number of events 6 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
ASPARTATE AMINOTRANSFERASE INCREASED
17.6%
12/68 • Number of events 14 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
4.2%
3/72 • Number of events 4 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
ALANINE AMINOTRANSFERASE INCREASED
20.6%
14/68 • Number of events 16 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
4.2%
3/72 • Number of events 4 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
GAMMA-GLUTAMYLTRANSFERASE INCREASED
11.8%
8/68 • Number of events 8 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
4.2%
3/72 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
RHINITIS
5.9%
4/68 • Number of events 4 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
BLOOD AND LYMPHATIC SYSTEM DISORDERS
LYMPHOPENIA
5.9%
4/68 • Number of events 4 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
EYE DISORDERS
OCULAR DISCOMFORT
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
NYSTAGMUS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
VASCULAR DISORDERS
HYPERTENSION
25.0%
17/68 • Number of events 28 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
CONSTIPATION
30.9%
21/68 • Number of events 28 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
20.8%
15/72 • Number of events 18 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
ASTHENIA
45.6%
31/68 • Number of events 43 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
50.0%
36/72 • Number of events 51 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
DIARRHOEA
16.2%
11/68 • Number of events 15 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
16.7%
12/72 • Number of events 13 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MUCOSAL INFLAMMATION
11.8%
8/68 • Number of events 9 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
6.9%
5/72 • Number of events 8 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
VOMITING
23.5%
16/68 • Number of events 25 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
19.4%
14/72 • Number of events 15 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
ABDOMINAL PAIN
11.8%
8/68 • Number of events 9 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
6.9%
5/72 • Number of events 5 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
DRY SKIN
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
4.2%
3/72 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
PARAESTHESIA
7.4%
5/68 • Number of events 6 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
BACK PAIN
11.8%
8/68 • Number of events 8 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
8.3%
6/72 • Number of events 7 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
BLOOD AND LYMPHATIC SYSTEM DISORDERS
FEBRILE NEUTROPENIA
4.4%
3/68 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
TRANSAMINASES INCREASED
5.9%
4/68 • Number of events 5 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
4.2%
3/72 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
ABDOMINAL DISCOMFORT
1.5%
1/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
EPISTAXIS
17.6%
12/68 • Number of events 15 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PLEURAL EFFUSION
2.9%
2/68 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
METABOLISM AND NUTRITION DISORDERS
DECREASED APPETITE
32.4%
22/68 • Number of events 24 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
20.8%
15/72 • Number of events 18 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
DYSGEUSIA
2.9%
2/68 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
4.2%
3/72 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
HYPERTHERMIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
C-REACTIVE PROTEIN INCREASED
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
BLOOD ALKALINE PHOSPHATASE INCREASED
4.4%
3/68 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
VASCULAR DISORDERS
EMBOLISM
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
CHEST PAIN
10.3%
7/68 • Number of events 11 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
8.3%
6/72 • Number of events 6 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
ERYTHEMA
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
4.2%
3/72 • Number of events 4 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
EYE DISORDERS
DIPLOPIA
4.4%
3/68 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
OEDEMA PERIPHERAL
13.2%
9/68 • Number of events 11 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
9.7%
7/72 • Number of events 7 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
STASIS DERMATITIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
VASCULAR DISORDERS
PERIPHERAL VENOUS DISEASE
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
SKIN EXFOLIATION
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
SARS-COV-2 TEST POSITIVE
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
COUGH
22.1%
15/68 • Number of events 19 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
9.7%
7/72 • Number of events 8 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
NEUTROPHIL COUNT DECREASED
13.2%
9/68 • Number of events 15 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
8.3%
6/72 • Number of events 8 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
XEROSIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
4.2%
3/72 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
FUNGAL INFECTION
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
DYSPNOEA
19.1%
13/68 • Number of events 17 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
22.2%
16/72 • Number of events 17 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
AMYLASE INCREASED
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RENAL AND URINARY DISORDERS
GLYCOSURIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
WEIGHT DECREASED
11.8%
8/68 • Number of events 8 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PRODUCTIVE COUGH
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
ANAL FISSURE
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
BLOOD LACTATE DEHYDROGENASE INCREASED
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
SPONDYLITIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
INGROWING NAIL
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
ROTATOR CUFF SYNDROME
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
ALOPECIA
5.9%
4/68 • Number of events 4 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
6.9%
5/72 • Number of events 5 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
METABOLISM AND NUTRITION DISORDERS
HYPERKALAEMIA
5.9%
4/68 • Number of events 4 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
4.2%
3/72 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
OEDEMA
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
4.2%
3/72 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
RASH
7.4%
5/68 • Number of events 6 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
11.1%
8/72 • Number of events 11 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
HEPATOBILIARY DISORDERS
HEPATIC CYTOLYSIS
14.7%
10/68 • Number of events 10 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
9.7%
7/72 • Number of events 8 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
PRURITUS
4.4%
3/68 • Number of events 4 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
11.1%
8/72 • Number of events 8 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RENAL AND URINARY DISORDERS
RENAL FAILURE
10.3%
7/68 • Number of events 7 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
NEUROPATHY PERIPHERAL
4.4%
3/68 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
SINUSITIS
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
BLOOD CREATININE INCREASED
7.4%
5/68 • Number of events 7 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
4.2%
3/72 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
LIPASE INCREASED
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PAIN
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
EYE DISORDERS
EYELID OEDEMA
2.9%
2/68 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
4.2%
3/72 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
METABOLISM AND NUTRITION DISORDERS
HYPERCALCAEMIA
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
DEVICE RELATED INFECTION
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
BLOOD THYROID STIMULATING HORMONE DECREASED
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
CYSTITIS ESCHERICHIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MUSCULOSKELETAL CHEST PAIN
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
5.6%
4/72 • Number of events 4 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
GINGIVITIS
4.4%
3/68 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
HYPERAESTHESIA
4.4%
3/68 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
PSYCHIATRIC DISORDERS
NEUROSIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
URINARY TRACT INFECTION FUNGAL
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
WEIGHT INCREASED
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
GASTROOESOPHAGEAL REFLUX DISEASE
5.9%
4/68 • Number of events 4 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
HEPATOBILIARY DISORDERS
CHOLESTASIS
7.4%
5/68 • Number of events 7 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
4.2%
3/72 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
PSYCHIATRIC DISORDERS
SLEEP DISORDER
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
4.2%
3/72 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
ERYSIPELAS
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
CREATININE RENAL CLEARANCE DECREASED
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
TRI-IODOTHYRONINE DECREASED
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
BONE PAIN
5.9%
4/68 • Number of events 5 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
ABDOMINAL DISTENSION
4.4%
3/68 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MUSCULOSKELETAL PAIN
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MALAISE
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
FALL
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
OSTEITIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
FEMUR FRACTURE
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
ARTHRALGIA
14.7%
10/68 • Number of events 10 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
PAIN IN EXTREMITY
8.8%
6/68 • Number of events 6 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
4.2%
3/72 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
BLOOD AND LYMPHATIC SYSTEM DISORDERS
LEUKOPENIA
7.4%
5/68 • Number of events 7 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
EYE DISORDERS
DRY EYE
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
DYSPHAGIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
TOXIC SKIN ERUPTION
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RENAL AND URINARY DISORDERS
ACUTE KIDNEY INJURY
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
PLATELET COUNT DECREASED
4.4%
3/68 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
SERUM FERRITIN INCREASED
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MYALGIA
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
5.6%
4/72 • Number of events 4 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
NECK PAIN
5.9%
4/68 • Number of events 4 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
CARDIAC DISORDERS
VENTRICULAR EXTRASYSTOLES
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
DYSARTHRIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MUSCULAR WEAKNESS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
APHTHOUS ULCER
7.4%
5/68 • Number of events 5 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
PILONIDAL CYST
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
TOOTH INFECTION
2.9%
2/68 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
FACE OEDEMA
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
STOMATITIS
5.9%
4/68 • Number of events 4 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
MUSCLE RUPTURE
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
ASPARTATE AMINOTRANSFERASE DECREASED
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
ALANINE AMINOTRANSFERASE DECREASED
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RENAL AND URINARY DISORDERS
CHRONIC KIDNEY DISEASE
7.4%
5/68 • Number of events 5 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
APICAL GRANULOMA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
GINGIVAL BLEEDING
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
TOOTH AVULSION
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
GINGIVAL PAIN
2.9%
2/68 • Number of events 4 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
PURPURA
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
RHINORRHOEA
2.9%
2/68 • Number of events 5 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
METABOLISM AND NUTRITION DISORDERS
HYPONATRAEMIA
1.5%
1/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
WHITE BLOOD CELL COUNT DECREASED
2.9%
2/68 • Number of events 4 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
METABOLISM AND NUTRITION DISORDERS
HYPOALBUMINAEMIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
LYMPHOCYTE COUNT DECREASED
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
GAMMA-GLUTAMYLTRANSFERASE DECREASED
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
METABOLISM AND NUTRITION DISORDERS
HYPOPHOSPHATAEMIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
HYPOAESTHESIA
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
ASPARTATE AMINOTRANSFERASE
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
PSYCHIATRIC DISORDERS
ANXIETY
7.4%
5/68 • Number of events 5 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
5.6%
4/72 • Number of events 4 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
INTERTRIGO
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
HERPES ZOSTER
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
BRONCHITIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
5.6%
4/72 • Number of events 4 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
ORAL HERPES
4.4%
3/68 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
PSYCHIATRIC DISORDERS
CONFUSIONAL STATE
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
POSTOPERATIVE WOUND COMPLICATION
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
ANGULAR CHEILITIS
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
DERMATITIS EXFOLIATIVE GENERALISED
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
DERMATITIS DIAPER
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
DEMENTIA WITH LEWY BODIES
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
EYE DISORDERS
EYE PAIN
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
ANAL INCONTINENCE
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
NON-CARDIAC CHEST PAIN
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
METABOLISM AND NUTRITION DISORDERS
IRON DEFICIENCY
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
ORAL FUNGAL INFECTION
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
SKIN HYPERPIGMENTATION
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
EYE DISORDERS
CONJUNCTIVITIS ALLERGIC
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
METABOLISM AND NUTRITION DISORDERS
HYPOGLYCAEMIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
ENDOCRINE DISORDERS
THYROID DISORDER
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
ABDOMINAL PAIN UPPER
8.8%
6/68 • Number of events 7 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
IMPAIRED HEALING
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
PSYCHIATRIC DISORDERS
INSOMNIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
6.9%
5/72 • Number of events 5 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RENAL AND URINARY DISORDERS
RENAL IMPAIRMENT
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
BLOOD AND LYMPHATIC SYSTEM DISORDERS
THROMBOCYTOSIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
HAEMOPTYSIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
CARDIAC DISORDERS
HAEMOPTYSIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RENAL AND URINARY DISORDERS
POLLAKIURIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
NEURALGIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
MENINGITIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
PERONEAL NERVE PALSY
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RENAL AND URINARY DISORDERS
DYSURIA
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RENAL AND URINARY DISORDERS
URINARY RETENTION
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
INFLUENZA
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
TONSILLITIS
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
VASCULAR DISORDERS
ORTHOSTATIC HYPOTENSION
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
RADIATION OESOPHAGITIS
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
METABOLISM AND NUTRITION DISORDERS
HYPOCALCAEMIA
1.5%
1/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
PHARYNGITIS
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
OVARIAN VEIN THROMBOSIS
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
IMMUNE SYSTEM DISORDERS
ANAPHYLACTIC SHOCK
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
INFUSION RELATED REACTION
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
BLOOD PRESSURE DECREASED
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
LUNG DISORDER
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
ENDOCRINE DISORDERS
HYPERTHYROIDISM
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RENAL AND URINARY DISORDERS
NEPHRITIS
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
HAEMORRHOIDAL HAEMORRHAGE
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
DYSAESTHESIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
SACRAL PAIN
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
FOOD POISONING
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
EAR AND LABYRINTH DISORDERS
HYPOACUSIS
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
BLOOD THYROID STIMULATING HORMONE INCREASED
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
VASCULAR DISORDERS
VENA CAVA THROMBOSIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
ATAXIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
COGNITIVE DISORDER
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
GENERAL PHYSICAL HEALTH DETERIORATION
4.4%
3/68 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
EAR AND LABYRINTH DISORDERS
DEAFNESS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
BALANCE DISORDER
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
GAIT DISTURBANCE
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
METASTASES TO MENINGES
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
BLOOD UREA INCREASED
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PULMONARY TOXICITY
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
COVID-19
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
INTERVERTEBRAL DISC PROTRUSION
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
DISCOMFORT
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PLEURITIC PAIN
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
4.2%
3/72 • Number of events 3 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
PRESYNCOPE
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
SUBCUTANEOUS HAEMATOMA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
METABOLISM AND NUTRITION DISORDERS
VITAMIN D DEFICIENCY
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
INFLUENZA LIKE ILLNESS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
PSYCHIATRIC DISORDERS
FLAT AFFECT
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
MELANODERMA
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
ENDOCRINE DISORDERS
ENDOCRINE DISORDER
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
THORACIC VERTEBRAL FRACTURE
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
DIZZINESS
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MUSCULOSKELETAL STIFFNESS
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
DISEASE PROGRESSION
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
RASH ERYTHEMATOUS
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RENAL AND URINARY DISORDERS
HAEMATURIA
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
EAR AND LABYRINTH DISORDERS
TINNITUS
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
VASCULAR DISORDERS
JUGULAR VEIN THROMBOSIS
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
RHINITIS ALLERGIC
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
PAIN IN JAW
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MUCOSAL DRYNESS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MUCOSAL HAEMORRHAGE
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
RECTAL HAEMORRHAGE
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
POST HERPETIC NEURALGIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
DENTAL CYST
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
RIB FRACTURE
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
VASCULAR DISORDERS
HYPOTENSION
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
OEDEMA MOUTH
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
RASH MACULO-PAPULAR
1.5%
1/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
CATHETER SITE INFLAMMATION
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SURGICAL AND MEDICAL PROCEDURES
CENTRAL VENOUS CATHETER REMOVAL
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
CARDIAC DISORDERS
CARDIAC FAILURE
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
HAEMOGLOBIN DECREASED
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
METABOLISM AND NUTRITION DISORDERS
STARVATION
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
PNEUMONIA
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
SCIATICA
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
TOOTH ABSCESS
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
BLOOD CREATINE PHOSPHOKINASE INCREASED
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
TREMOR
1.5%
1/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
ASPIRATION
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
CHEST DISCOMFORT
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
DEVICE RELATED THROMBOSIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
MIGRAINE
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
SEIZURE
2.9%
2/68 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
BLOOD AND LYMPHATIC SYSTEM DISORDERS
FEBRILE BONE MARROW APLASIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
HERPES VIRUS INFECTION
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
BLOOD AND LYMPHATIC SYSTEM DISORDERS
HAEMATOTOXICITY
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
PERIODONTITIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
LIPIDS ABNORMAL
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
BLOOD AND LYMPHATIC SYSTEM DISORDERS
LYMPHOCYTOSIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
SKIN LESION
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
EYE DISORDERS
EYE PRURITUS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
CARDIAC DISORDERS
PALPITATIONS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
GASTROINTESTINAL PAIN
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
NASOPHARYNGITIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
GASTROINTESTINAL DISORDER
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
EYE DISORDERS
VISUAL ACUITY REDUCED
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
URTICARIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RENAL AND URINARY DISORDERS
POLYURIA
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
ABSCESS
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
VITILIGO
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
WOUND COMPLICATION
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
TROPONIN I INCREASED
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
SUBCUTANEOUS ABSCESS
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
CEREBRAL THROMBOSIS
1.5%
1/68 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
0.00%
0/72 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
CARDIAC DISORDERS
TACHYCARDIA
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RENAL AND URINARY DISORDERS
BLADDER DILATATION
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INFECTIONS AND INFESTATIONS
GASTROENTERITIS
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
METABOLISM AND NUTRITION DISORDERS
HYPERLIPASAEMIA
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
VASCULAR DISORDERS
SUPERFICIAL VEIN THROMBOSIS
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
INTRACRANIAL PRESSURE INCREASED
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
RADIATION ALOPECIA
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
RADIATION SKIN INJURY
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
DYSPEPSIA
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
2.8%
2/72 • Number of events 2 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
INVESTIGATIONS
ALANINE AMINOTRANSFERASE
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
ODYNOPHAGIA
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
SKIN TOXICITY
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
DYSPHONIA
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
NERVOUS SYSTEM DISORDERS
RESTLESS LEGS SYNDROME
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
GASTROINTESTINAL DISORDERS
MOUTH ULCERATION
0.00%
0/68 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.
1.4%
1/72 • Number of events 1 • from treatment start to 24 months after end of treatment
Safety of the chemotherapy and immunotherapy will be assessed by toxicities that will occur either in the induction treatment or the maintenance treatment. Toxicities will be evaluated according to NCI CTCAE v5.0, in terms of kind, grade, time of onset, reversibility.

Additional Information

Justine Lequesne

Centre François Baclesse

Phone: 0231455002

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place