Trial Outcomes & Findings for Atezolizumab, Pemetrexed Disodium, Cisplatin, and Surgery With or Without Radiation Therapy in Treating Patients With Stage I-III Pleural Malignant Mesothelioma (NCT NCT03228537)
NCT ID: NCT03228537
Last Updated: 2025-11-10
Results Overview
The number of participants who received at least two cycles of the triplet neoadjuvant therapy getting at least one dose of maintenance therapy.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Duration of treatment until first dose of maintenance therapy. Includes 21 day cycles of neoadjuvant chemo and surgery - extrapleural pneumonectomy or pleurectomy/decortication (radiation therapy for participants who received extrapleural pneumonectomy).
Results posted on
2025-11-10
Participant Flow
29 participants were registered to the study, 1 participant was ineligible, so 28 participants received protocol treatment for Step 1, Neoadjuvant.
Participant milestones
| Measure |
Treatment (Chemotherapy, Surgery +/- RT, Maintenance)
NEOADJUVANT: Patients receive atezolizumab IV over 30-60 minutes, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 2 hours on day 1. Cycles repeats every 21 days for 4 cycles in the absence of disease progression or unexpected toxicity.
SURGERY: Within 21-90 days after completion of neoadjuvant therapy, patients undergo extrapleural pneumonectomy (EPP) or pleurectomy/decortication (PD). Patients who undergo EPP will then undergo radiation therapy.
MAINTENANCE: Within 90 days after completion of either PD or radiation (post-EPP), patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unexpected toxicity.
|
|---|---|
|
Neoadjuvant
STARTED
|
28
|
|
Neoadjuvant
COMPLETED
|
21
|
|
Neoadjuvant
NOT COMPLETED
|
7
|
|
Surgery
STARTED
|
19
|
|
Surgery
COMPLETED
|
16
|
|
Surgery
NOT COMPLETED
|
3
|
|
Maintenance
STARTED
|
15
|
|
Maintenance
COMPLETED
|
4
|
|
Maintenance
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Treatment (Chemotherapy, Surgery +/- RT, Maintenance)
NEOADJUVANT: Patients receive atezolizumab IV over 30-60 minutes, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 2 hours on day 1. Cycles repeats every 21 days for 4 cycles in the absence of disease progression or unexpected toxicity.
SURGERY: Within 21-90 days after completion of neoadjuvant therapy, patients undergo extrapleural pneumonectomy (EPP) or pleurectomy/decortication (PD). Patients who undergo EPP will then undergo radiation therapy.
MAINTENANCE: Within 90 days after completion of either PD or radiation (post-EPP), patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unexpected toxicity.
|
|---|---|
|
Neoadjuvant
Adverse Event
|
2
|
|
Neoadjuvant
Progression/Relapse
|
4
|
|
Neoadjuvant
Death
|
1
|
|
Surgery
Death
|
1
|
|
Surgery
Other - Not Protocol Specified
|
2
|
|
Maintenance
Refusal Unrelated to Adverse Event
|
1
|
|
Maintenance
Progression/Relapse
|
10
|
Baseline Characteristics
Atezolizumab, Pemetrexed Disodium, Cisplatin, and Surgery With or Without Radiation Therapy in Treating Patients With Stage I-III Pleural Malignant Mesothelioma
Baseline characteristics by cohort
| Measure |
Treatment (Chemotherapy, Surgery +/- RT, Maintenance)
n=28 Participants
NEOADJUVANT: Patients receive atezolizumab IV over 30-60 minutes, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 2 hours on day 1. Cycles repeats every 21 days for 4 cycles in the absence of disease progression or unexpected toxicity.
SURGERY: Within 21-90 days after completion of neoadjuvant therapy, patients undergo extrapleural pneumonectomy (EPP) or pleurectomy/decortication (PD). Patients who undergo EPP will then undergo radiation therapy.
MAINTENANCE: Within 90 days after completion of either PD or radiation (post-EPP), patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unexpected toxicity.
|
|---|---|
|
Age, Continuous
|
68.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic · No
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic · Unknown
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
1 Participants
n=5 Participants
|
|
Surgery
Extrapleural Pneumonectomy (EPP)
|
4 Participants
n=5 Participants
|
|
Surgery
Pleurectomy/Decortication (PD)
|
24 Participants
n=5 Participants
|
|
Performance Status
0
|
15 Participants
n=5 Participants
|
|
Performance Status
1
|
13 Participants
n=5 Participants
|
|
Weight Loss Past 6 Months
<6%
|
23 Participants
n=5 Participants
|
|
Weight Loss Past 6 Months
5-<10%
|
4 Participants
n=5 Participants
|
|
Weight Loss Past 6 Months
Pending
|
1 Participants
n=5 Participants
|
|
Baseline Disease Status mRECIST
Measurable
|
22 Participants
n=5 Participants
|
|
Baseline Disease Status mRECIST
Not Assessable
|
6 Participants
n=5 Participants
|
|
Baseline Disease Status RECIST
Measurable
|
14 Participants
n=5 Participants
|
|
Baseline Disease Status RECIST
Non-Measurable
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Duration of treatment until first dose of maintenance therapy. Includes 21 day cycles of neoadjuvant chemo and surgery - extrapleural pneumonectomy or pleurectomy/decortication (radiation therapy for participants who received extrapleural pneumonectomy).Population: Participants that received at least 2 cycles of neoadjuvant Cisplatin-Pemetrexed-Atezolizumab.
The number of participants who received at least two cycles of the triplet neoadjuvant therapy getting at least one dose of maintenance therapy.
Outcome measures
| Measure |
Treatment (Chemotherapy, Surgery +/- RT, Maintenance)
n=25 Participants
NEOADJUVANT: Patients receive atezolizumab IV over 30-60 minutes, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 2 hours on day 1. Cycles repeats every 21 days for 4 cycles in the absence of disease progression or unexpected toxicity.
SURGERY: Within 21-90 days after completion of neoadjuvant therapy, patients undergo extrapleural pneumonectomy (EPP) or pleurectomy/decortication (PD). Patients who undergo EPP will then undergo radiation therapy.
MAINTENANCE: Within 90 days after completion of either PD or radiation (post-EPP), patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unexpected toxicity.
|
|---|---|
|
Feasibility of Neoadjuvant Cisplatin-Pemetrexed-Atezolizumab, Surgery +/- Radiation, and Maintenance Therapy.
|
15 Participants
|
PRIMARY outcome
Timeframe: Duration of treatment and follow-up until death or 3 years post Step 1 registration.Population: Participants who were assessed for adverse events.
The number of participants that experienced a Grade 4-5 immune-related adverse event. The regimen was considered safe if no participants experienced a Grade 4-5 immune-related AE.
Outcome measures
| Measure |
Treatment (Chemotherapy, Surgery +/- RT, Maintenance)
n=28 Participants
NEOADJUVANT: Patients receive atezolizumab IV over 30-60 minutes, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 2 hours on day 1. Cycles repeats every 21 days for 4 cycles in the absence of disease progression or unexpected toxicity.
SURGERY: Within 21-90 days after completion of neoadjuvant therapy, patients undergo extrapleural pneumonectomy (EPP) or pleurectomy/decortication (PD). Patients who undergo EPP will then undergo radiation therapy.
MAINTENANCE: Within 90 days after completion of either PD or radiation (post-EPP), patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unexpected toxicity.
|
|---|---|
|
Safety of Neoadjuvant Cisplatin-Pemetrexed-Atezolizumab, Surgery +/- Radiation, and Maintenance Therapy.
|
1 Participants
|
SECONDARY outcome
Timeframe: Duration of treatment and follow-up until death or 3 years post Step 1 registration.Population: Eligible and evaluable participants.
From date of registration to Step 1 to date of first documentation of progression by RECIST 1.1 and modified RECIST 1.1, symptomatic deterioration, or death due to any cause. Participants last known to be alive and progression free are censored at date of last disease assessment.
Outcome measures
| Measure |
Treatment (Chemotherapy, Surgery +/- RT, Maintenance)
n=28 Participants
NEOADJUVANT: Patients receive atezolizumab IV over 30-60 minutes, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 2 hours on day 1. Cycles repeats every 21 days for 4 cycles in the absence of disease progression or unexpected toxicity.
SURGERY: Within 21-90 days after completion of neoadjuvant therapy, patients undergo extrapleural pneumonectomy (EPP) or pleurectomy/decortication (PD). Patients who undergo EPP will then undergo radiation therapy.
MAINTENANCE: Within 90 days after completion of either PD or radiation (post-EPP), patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unexpected toxicity.
|
|---|---|
|
Progression Free Survival (PFS)
RECIST 1.1
|
9.5 Months
Interval 6.6 to 13.0
|
|
Progression Free Survival (PFS)
mRECIST 1.1
|
18.4 Months
Interval 6.6 to 25.1
|
SECONDARY outcome
Timeframe: 3 years after the last accrualPopulation: Eligible and evaluable participants.
From date of initial registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact.
Outcome measures
| Measure |
Treatment (Chemotherapy, Surgery +/- RT, Maintenance)
n=28 Participants
NEOADJUVANT: Patients receive atezolizumab IV over 30-60 minutes, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 2 hours on day 1. Cycles repeats every 21 days for 4 cycles in the absence of disease progression or unexpected toxicity.
SURGERY: Within 21-90 days after completion of neoadjuvant therapy, patients undergo extrapleural pneumonectomy (EPP) or pleurectomy/decortication (PD). Patients who undergo EPP will then undergo radiation therapy.
MAINTENANCE: Within 90 days after completion of either PD or radiation (post-EPP), patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unexpected toxicity.
|
|---|---|
|
Overall Survival (OS)
|
31.5 Months
Interval 18.4 to
Less than half of the remaining participants died (more than half are still alive) after reaching the median survival.
|
SECONDARY outcome
Timeframe: Duration of treatment and follow-up until death or 3 years post Step 1 registration.Population: Eligible and evaluable participants with measurable disease. 14 participants had measurable disease according to the RECIST which measures lesions from an x-ray, CT, or MRI. 22 participants had measurable disease according to the mRECIST which measures lesions as the sum of 6 CT cuts.
Percentage of participants with confirmed and unconfirmed, complete and partial, defined by RECIST 1.1 and mRECIST for Pleural Tumors
Outcome measures
| Measure |
Treatment (Chemotherapy, Surgery +/- RT, Maintenance)
n=22 Participants
NEOADJUVANT: Patients receive atezolizumab IV over 30-60 minutes, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 2 hours on day 1. Cycles repeats every 21 days for 4 cycles in the absence of disease progression or unexpected toxicity.
SURGERY: Within 21-90 days after completion of neoadjuvant therapy, patients undergo extrapleural pneumonectomy (EPP) or pleurectomy/decortication (PD). Patients who undergo EPP will then undergo radiation therapy.
MAINTENANCE: Within 90 days after completion of either PD or radiation (post-EPP), patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unexpected toxicity.
|
|---|---|
|
Response Rate (RR)
RECIST 1.1
|
7 Participants
|
|
Response Rate (RR)
mRECIST 1.1
|
10 Participants
|
Adverse Events
Chemotherapy + Atezolizumab
Serious events: 11 serious events
Other events: 28 other events
Deaths: 6 deaths
Surgery
Serious events: 0 serious events
Other events: 16 other events
Deaths: 3 deaths
Maintenance
Serious events: 2 serious events
Other events: 15 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Chemotherapy + Atezolizumab
n=28 participants at risk
Participants receive atezolizumab IV over 30-60 minutes, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 2 hours on day 1. Cycles repeats every 21 days for 4 cycles in the absence of disease progression or unexpected toxicity.
|
Surgery
n=19 participants at risk
Within 21-90 days after completion of neoadjuvant therapy, participants undergo EPP or PD. Participants who undergo EPP will then undergo RT.
|
Maintenance
n=15 participants at risk
Within 90 days after completion of either PD or radiation (post-EPP), participants receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unexpected toxicity.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
7.1%
2/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
2/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Gastrointestinal disorders
Gastritis
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Gastrointestinal disorders
Nausea
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
General disorders
Fever
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
General disorders
Infusion related reaction
|
10.7%
3/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Infections and infestations
Lung infection
|
7.1%
2/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Infections and infestations
Sepsis
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Injury, poisoning and procedural complications
Injury, poison and procedural complications - Other
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Investigations
Neutrophil count decreased
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
Other adverse events
| Measure |
Chemotherapy + Atezolizumab
n=28 participants at risk
Participants receive atezolizumab IV over 30-60 minutes, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 2 hours on day 1. Cycles repeats every 21 days for 4 cycles in the absence of disease progression or unexpected toxicity.
|
Surgery
n=19 participants at risk
Within 21-90 days after completion of neoadjuvant therapy, participants undergo EPP or PD. Participants who undergo EPP will then undergo RT.
|
Maintenance
n=15 participants at risk
Within 90 days after completion of either PD or radiation (post-EPP), participants receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unexpected toxicity.
|
|---|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
2/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Investigations
Creatinine increased
|
21.4%
6/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
26.3%
5/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
26.7%
4/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Investigations
Lymphocyte count decreased
|
17.9%
5/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Investigations
Neutrophil count decreased
|
39.3%
11/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Investigations
Platelet count decreased
|
7.1%
2/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
15.8%
3/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Investigations
Weight gain
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Investigations
Weight loss
|
7.1%
2/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
10.5%
2/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Investigations
White blood cell decreased
|
28.6%
8/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Anorexia
|
42.9%
12/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
21.1%
4/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
40.0%
6/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.7%
3/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.1%
2/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.1%
2/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
15.8%
3/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
46.7%
7/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.1%
2/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
15.8%
3/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
17.9%
5/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
15.8%
3/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
26.7%
4/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
20.0%
3/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.7%
3/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
17.9%
5/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.6%
8/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
26.3%
5/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
33.3%
5/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.7%
3/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
10.5%
2/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
7.1%
2/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
33.3%
5/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Nervous system disorders
Dizziness
|
21.4%
6/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Nervous system disorders
Dysgeusia
|
21.4%
6/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Nervous system disorders
Headache
|
28.6%
8/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.1%
2/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
10.5%
2/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Psychiatric disorders
Anxiety
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Psychiatric disorders
Insomnia
|
7.1%
2/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Renal and urinary disorders
Urinary frequency
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.4%
6/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
26.7%
4/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
32.1%
9/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
10.5%
2/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
40.0%
6/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
14.3%
4/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
2/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
20.0%
3/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
7.1%
2/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
10.5%
2/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
7.1%
2/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.1%
2/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.7%
3/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
20.0%
3/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Vascular disorders
Hypertension
|
14.3%
4/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Vascular disorders
Hypotension
|
7.1%
2/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Vascular disorders
Thromboembolic event
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Blood and lymphatic system disorders
Anemia
|
46.4%
13/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
47.4%
9/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
66.7%
10/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Cardiac disorders
Atrial fibrillation
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Endocrine disorders
Hyperthyroidism
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Endocrine disorders
Hypothyroidism
|
7.1%
2/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Eye disorders
Blurred vision
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Eye disorders
Eye disorders-Other
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.9%
5/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Gastrointestinal disorders
Constipation
|
39.3%
11/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
10.5%
2/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
40.0%
6/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
2/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.1%
2/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Gastrointestinal disorders
Nausea
|
75.0%
21/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
15.8%
3/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
46.7%
7/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
7/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
15.8%
3/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
General disorders
Chills
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
General disorders
Edema limbs
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
General disorders
Fatigue
|
57.1%
16/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
26.3%
5/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
73.3%
11/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
General disorders
Fever
|
14.3%
4/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
General disorders
General disorders and admin site conditions - Other
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
General disorders
Non-cardiac chest pain
|
10.7%
3/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
21.1%
4/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
40.0%
6/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
General disorders
Pain
|
7.1%
2/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
26.3%
5/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
26.7%
4/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Infections and infestations
Lung infection
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Infections and infestations
Pleural infection
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Infections and infestations
Wound infection
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
10.5%
2/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
5.3%
1/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Investigations
Alanine aminotransferase increased
|
10.7%
3/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
0.00%
0/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
6.7%
1/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
|
Investigations
Alkaline phosphatase increased
|
3.6%
1/28 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
10.5%
2/19 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
13.3%
2/15 • Duration of treatment and follow up until death or 3 years post registration to Step 1.
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
|
Additional Information
Lung Committee Statistician
SWOG Statistics and Data Management Center
Phone: 2066674623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60