Gastric Cancer
Conditions
Brief summary
Primary Objective: \- To compare the 3-year progression free survival (PFS) in the two treatment arms. Secondary Objectives: * Overall survival (OS). * Postoperative pathological stage and R0 (complete) resection rate. * Safety: Toxicities associated with neoadjuvant chemotherapy, surgery, morbidity/mortality, toxicity of adjuvant chemotherapy.
Detailed description
Participants in the neoadjuvant chemotherapy arm were treated for 3 cycles (1 cycle is 21 days) before surgery and treated for a year with S-1. Participants in the adjuvant chemotherapy arm underwent surgery and were treated for a year with S-1. All participants were followed during and after the study treatment until death or disease progression, whichever comes first.
Interventions
Pharmaceutical form:solution for infusion Route of administration: intravenous
Pharmaceutical form:solution for infusion Route of administration: intravenous
DRUGS-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + 5-chloro-2, 4-dihydroxypyridine (CDHP) (Gimeracil) + Oxo (Oteracil)
Pharmaceutical form:Tablet Route of administration: Oral
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
: * Participants with new histologically confirmed, newly diagnosed, localized gastric or gastro-oesophageal adenocarcinoma, that is considered resectable. * Participants with clinical stage (T2-3/N(+), T4/N(+/-):N positive means greater than or equal to \[\>=\] 8 in hour axis). * Signed informed consent.
Exclusion criteria
* Aged less than (\<) 20 years or \>= 76 years. Performance status \>=2 in Eastern Cooperative Oncology Group (ECOG) scale * The participants who had the history of other malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix which had been already successfully treated. * Previous surgery on neoplasm of stomach. * Participants who did not completely recovered from surgery. * Distant metastases (M1) to other organs including distant nodal groups (retropancreatic, para-aortic, portal, retroperitoneal, mesenteric node). severe/unstable angina, coronary artery bypass graft, congestive heart failure, transient ischemic attack within 6 months prior to enrollment in the study. * Any previous palliative, adjuvant or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy, for the currently treated gastric cancer. * Participants with active infection or sepsis. * Intolerance of oral taking or malabsorption: lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of S-1. Ileus, chronic inflammatory intestinal disease or extensive resection of the small intestine and other disorders which limit drug resorption. This includes gastric dumping syndrome, indications of accelerated passage through the small intestine and indications of resorption disorders after intestinal surgery. * Greater than or equal to grade 2 severe tumour haemorrhage. * Simultaneous participation in another study, or participation in another study within 4 weeks of commencement of this study. * Pregnant or lactating participants. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With 3-Year Progression-Free Survival (PFS), as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 | 3 years | PFS was defined as the time from randomization to objective tumor progression, or recurrence or death. Progressive disease (PD) was defined as follows: 1) In Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) Arm, PD was determined according to the RECIST 1.1 Criteria during the neo-adjuvant chemotherapy period; 2) Irrespective of curative resection, if an intraoperative distant metastasis was observed or a distant metastasis was reported from pathology, it was considered PD; 3) If residual cancer cells were visually identified at the resection margin during surgery but could not be completely resected (R2), it was considered PD; 4) If residual cancer cells were finally confirmed at the resection margin during postoperative histology (R1), it was considered PD; 5) In case of finding a recurrence/distant metastasis or a new lesion during follow-up after R0 complete resection, it was defined as the first tumor assessment date when it was observed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Post-Operative Pathological Stage Response | Up to 10 years | TNM pathological stage was determined according to standardized histopathology and the American Joint Committee on Cancer (AJCC) staging system 7th Edition (Stages 0,IA,IB,IIA,IIB,IIIA,IIIB,IIIC and IV). Stage 0=carcinoma in situ with no metastatic potential; Stage IA=T1N0M0; Stage IB=T2N0M0,T1N1M0; Stage IIA=T3N0M0,T2N1M0,T1N2M0;Stage IIB=T4aN0M0,T3N1M0,T2N2M0,T1N3M0;Stage IIIA=T4aN1M0,T3N2M0,T2N3M0;Stage IIIB=T4bN0-1M0,T4aN2M0,T3N3M0;Stage IIIC=T4bN2-3M0, T4aN3M0 and Stage IV= distant metastases (M1) at diagnosis; where T denotes tumor size where T1: tumor invades lamina propria, muscularis mucosae, or submucosa; T2: invades muscularis propria; T3: invasion of subserosa; T4: T4a: penetrate serosa (visceral peritoneum) T4b: invade adjacent tissue and N denotes nodes affected where N1:1-2 positive lymph nodes; N2:3-6 positive lymph nodes; N3: 7 or more positive lymph nodes and M denotes metastases where M0: no distant metastases. Higher stages indicates worse outcome. |
| Percentage of Participants With R0 Resection | Up to 10 years | Tumor condition was explained according to the Residual Tumor (R) Classification: R0; No residual cancer (negative cross-section), R1; Microscopically observed residual cancer (positive cross-section), R2; Macroscopically observed residual cancer. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From randomization up to 30 days after last dose of study drug (maximum duration: up to 10 years) | TEAEs were defined as adverse events (AE) that appeared or worsened during the treatment period (up to 30 days after the last dose of the investigational product). SAE was an AE or adverse drug reaction at any dose of the investigational product that corresponded to one of the following: resulting in death or is life threatening; requiring in-patient hospitalization or prolongation of existing hospitalization; resulting in persistent or significant disability of dysfunction; resulting in congenital anomaly or birth defect; important medical event. |
| Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years) | NCI-CTCAE version 4.03 was used to determine Grade(Gr),where Gr refers to severity of AE:Gr 1:mild; asymptomatic/mild symptoms; Gr 2:moderate;minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Hemoglobin(Hb)(Anemia) were based on Gr1:\<lower limit of normal (LLN)-10.0g/dL; Gr2:\<10.0-8.0g/dL; Gr3:\<8.0g/dL; Gr4:life-threatening consequences;Gr5:death. Hb increased:Gr 1:increase(incr.) in \>0-2g/dL above upper limit of normal(ULN);Gr2: incr. in \>2-4g/dL above ULN; Gr3:incr. in \>4gm/dL above ULN. White blood cell (WBC) decreased: Gr1:\<LLN - 3000/mm\^3;Gr2: \<3000-2000/mm\^3; Gr3:\<2000-1000/mm\^3;Gr4:\<1000/mm\^3. WBC (Leukocytosis):Gr3:\>100,000/mm\^3, Gr4:clinical manifestations of leucostasis;Gr5:Death. Abnormal Neutrophil count (ANC):- Gr1:\<LLN-1500/mm\^3;Gr2:\<1500-1000/mm\^3; Gr3: \<1000-500/mm\^3; Gr4:\<500/mm\^3. Platelet count decreased: Gr1:\<LLN-75,000/mm\^3;Gr2:\<75,000-50,000/mm\^3;Gr3:\<50,000-25,000/mm\^3;Gr4:\<25,000/mm\^3. |
| Overall Survival (OS) | From randomization to date of death due to any cause (maximum duration: up to 10 years) | OS was defined as the time from randomization to death due to any cause. Analyzed using Kaplan-Meier method. |
| Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years) | NCI-CTCAE version 4.03 was used to determine Gr,where Gr refers to severity of AE:Gr 1:mild; asymptomatic/mild symptoms; Gr 2:moderate;minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Calcium(Hypocalcemia) were based on Gr1: Corrected serum calcium of \<LLN-8.0 mg/dL; Gr2: Corrected serum calcium of \<8.0-7.0 mg/dL; Gr3: Corrected serum calcium of \<7.0-6.0 mg/dL ; Gr4: Corrected serum calcium of \<6.0 mg/dL;Gr5:death. Calcium(Hypercalcemia):Gr 1: Corrected serum calcium of \>ULN -11.5 mg/dL; Gr2: Corrected serum calcium of \>11.5-12.5 mg/dL; Gr3: Corrected serum calcium of \>12.5-13.5 mg/dL; Gr4: Corrected serum calcium of \>13.5 mg/dL;Gr5:Death. Creatinine increased: Gr 1: \>1-1.5\*baseline; \>ULN-1.5\*ULN; Gr2: \>1.5-3.0\*baseline; \>1.5-3.0\*ULN; Gr3: \>3.0 baseline; \>3.0-6.0\*ULN; Gr4: \>6.0 x ULN. Albumin(Hypoalbuminemia): Gr 1: \<LLN-3 g/dL; Gr2: \<3-2 g/dL; Gr3: \<2 g/dL; Gr4:life-threatening consequences;Gr5:Death. |
| Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years) | NCI-CTCAE version 4.03 was used to determine Gr, where Gr refers to severity of AE: Gr 1:mild; asymptomatic/mild symptoms; Gr 2:moderate; minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Aspartate and alanine aminotransferase increased were based on Gr1: \>ULN-3.0\*ULN; Gr2: \>3.0-5.0\*ULN; Gr3: \>5.0-20.0\*ULN; Gr4: \>20.0\*ULN. Blood bilirubin increased: Gr1: \>ULN-1.5\*ULN; Gr2 \>1.5-3.0\*ULN; Gr3: \>3.0-10.0\*ULN; Gr4: \>10.0\*ULN. Alkaline phosphatase increased: Gr1: \>ULN-2.5\*ULN; Gr2: \>2.5-5.0\*ULN; Gr3: \>5.0-20.0\*ULN; Gr4: \>20.0\*ULN. Glucose (Hypoglycemia): Gr 1: \<LLN-55 mg/dL; Gr2: \<55-40 mg/dL;Gr3: \<40-30 mg/dL; Gr4: \<30 mg/dL; Gr5:Death. Glucose (Hyperglycemia): Gr 1: Fasting glucose value \>ULN-160 mg/dL; Gr2: Fasting glucose value \>160-250 mg/dL; Gr3: \>250-500 mg/dL; Gr4: \>500 mg/dL; Gr5: Death. |
| Number of Participants With Shift of Laboratory Parameters (Creatinine Clearance [Chronic Kidney Disease]) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years) | NCI-CTCAE version 4.03 was used to determine Gr, where Gr refers to severity of AE: Gr 1: mild; asymptomatic/mild symptoms; Gr 2: moderate; minimal; Gr 3: severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Creatinine Clearance(Chronic kidney disease) were based on: Gr 1: estimated glomerular filtration rate (eGFR) or creatinine clearance (CrCl) \<LLN-60ml/min/1.73 m\^2; Gr2: eGFR or CrCl 59-30 ml/min/1.73 m\^2; Gr3: eGFR or CrCl 29-15 ml/min/1.73 m\^2; Gr4: eGFR or CrCl \<15 ml/min/1.73 m\^2; Gr5: Death. |
| Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years) | NCI-CTCAE version 4.03 was used to determine Gr,where Gr refers to severity of AE: Gr 1: mild; asymptomatic/mild symptoms; Gr 2: moderate; minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Sodium (Hyponatremia) were based on Gr1: \<LLN-130 mmol/L; Gr3: \<130-120 mmol/L; Gr4: \<120 mmol/L; life-threatening consequences; Gr5: death. Sodium (Hypernatremia):Gr 1: \>ULN-150 mmol/L; Gr2: \>150-155 mmol/L; Gr3:\>155-160 mmol/L;hospitalization; Gr4: \>160 mmol/L; life-threatening consequences; Gr5: Death. Potassium (Hypokalemia): Gr 1: \<LLN-3.0 mmol/L; Gr2: \<LLN-3.0 mmol/L; symptomatic; intervention indicated; Gr3: \<3.0-2.5 mmol/L; hospitalization indicated; Gr4: \<2.5 mmol/L; life-threatening consequences; Gr5: Death; Potassium(Hyperkalemia): Gr 1: \>ULN-5.5 mmol/L; Gr2: \>5.5-6.0 mmol/L; Gr3: \>6.0-7.0 mmol/L; hospitalization indicated; Gr4: \>7.0 mmol/L; life-threatening consequences; Gr5: Death. |
Countries
South Korea
Participant flow
Recruitment details
The study was conducted at 18 sites in Korea. A total of 693 participants were screened between 30 December 2011 to 02 January 2019, of which, 163 were screen failures. Screen failures were mainly due to inclusion criteria not met.
Pre-assignment details
Total of 530 participants were enrolled and randomized in study. Assignment was done using Interactive Web-Response System (IWRS) in 1:1 to treatment arms. Randomization was stratified by site and Tumor size, Lymph Nodes affected, Metastases (TNM) \[T2/N+,T3-4/N+,T4/N-\] stage.
Participants by arm
| Arm | Count |
|---|---|
| Surgery + Adjuvant Chemotherapy (SC) Participants underwent surgery within 2 weeks after randomization followed by adjuvant chemotherapy with S-1 \[(Gimeracil) + Oxo (Oteracil)\] 40 mg/m\^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 10 years). | 264 |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) Participants received neo-adjuvant chemotherapy with Docetaxel 50 mg/m\^2 IV for \>= 1 hr on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m\^2 IV for \>=2 hr on Day 1 of each treatment cycle plus S-1 \[(Gimeracil) + Oxo (Oteracil)\] 40 mg/m\^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 \[(Gimeracil) + Oxo (Oteracil)\] 40 mg/m\^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 10 years). | 266 |
| Total | 530 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 4 |
| Overall Study | Other than specified above | 5 | 10 |
| Overall Study | Withdrawal by Subject | 32 | 41 |
Baseline characteristics
| Characteristic | Surgery + Adjuvant Chemotherapy (SC) | Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Total |
|---|---|---|---|
| Age, Continuous | 57.28 years STANDARD_DEVIATION 10.09 | 57.11 years STANDARD_DEVIATION 10.03 | 57.19 years STANDARD_DEVIATION 10.05 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 50 Participants | 59 Participants | 109 Participants |
| Sex: Female, Male Male | 214 Participants | 207 Participants | 421 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 91 / 264 | 78 / 266 |
| other Total, other adverse events | 141 / 195 | 201 / 241 |
| serious Total, serious adverse events | 57 / 195 | 102 / 241 |
Outcome results
Primary
Percentage of Participants With 3-Year Progression-Free Survival (PFS), as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1
PFS was defined as the time from randomization to objective tumor progression, or recurrence or death. Progressive disease (PD) was defined as follows: 1) In Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) Arm, PD was determined according to the RECIST 1.1 Criteria during the neo-adjuvant chemotherapy period; 2) Irrespective of curative resection, if an intraoperative distant metastasis was observed or a distant metastasis was reported from pathology, it was considered PD; 3) If residual cancer cells were visually identified at the resection margin during surgery but could not be completely resected (R2), it was considered PD; 4) If residual cancer cells were finally confirmed at the resection margin during postoperative histology (R1), it was considered PD; 5) In case of finding a recurrence/distant metastasis or a new lesion during follow-up after R0 complete resection, it was defined as the first tumor assessment date when it was observed.
Time frame: 3 years
Population: Full Analysis Set (FAS): included all randomized participants who satisfied inclusion/exclusion criteria and had at least one tumor assessment after baseline visit (Day 0). The CSC Arm included all participants exposed to at least one dose of Docetaxel+Oxaliplatin+S-1 investigational products. The SC Arm included all participants who had surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Surgery + Adjuvant Chemotherapy (SC) | Percentage of Participants With 3-Year Progression-Free Survival (PFS), as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 | 60.24 percentage of participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Percentage of Participants With 3-Year Progression-Free Survival (PFS), as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 | 66.82 percentage of participants |
Comparison: Analysis was performed using Kaplan-Meier method. Comparison was stratified based on site and TNM classification (T4/N-, T2/N+, T3-4/N+).p-value: 0.0152Stratified Log Rank
Secondary
Number of Participants With Post-Operative Pathological Stage Response
TNM pathological stage was determined according to standardized histopathology and the American Joint Committee on Cancer (AJCC) staging system 7th Edition (Stages 0,IA,IB,IIA,IIB,IIIA,IIIB,IIIC and IV). Stage 0=carcinoma in situ with no metastatic potential; Stage IA=T1N0M0; Stage IB=T2N0M0,T1N1M0; Stage IIA=T3N0M0,T2N1M0,T1N2M0;Stage IIB=T4aN0M0,T3N1M0,T2N2M0,T1N3M0;Stage IIIA=T4aN1M0,T3N2M0,T2N3M0;Stage IIIB=T4bN0-1M0,T4aN2M0,T3N3M0;Stage IIIC=T4bN2-3M0, T4aN3M0 and Stage IV= distant metastases (M1) at diagnosis; where T denotes tumor size where T1: tumor invades lamina propria, muscularis mucosae, or submucosa; T2: invades muscularis propria; T3: invasion of subserosa; T4: T4a: penetrate serosa (visceral peritoneum) T4b: invade adjacent tissue and N denotes nodes affected where N1:1-2 positive lymph nodes; N2:3-6 positive lymph nodes; N3: 7 or more positive lymph nodes and M denotes metastases where M0: no distant metastases. Higher stages indicates worse outcome.
Time frame: Up to 10 years
Population: Analysis was performed on FAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Post-Operative Pathological Stage Response | Stage IA | 9 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Post-Operative Pathological Stage Response | Stage IIIA | 35 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Post-Operative Pathological Stage Response | Stage IIA | 30 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Post-Operative Pathological Stage Response | Stage IIIB | 49 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Post-Operative Pathological Stage Response | Stage IB | 18 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Post-Operative Pathological Stage Response | Stage IIIC | 46 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Post-Operative Pathological Stage Response | Stage IIB | 25 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Post-Operative Pathological Stage Response | Stage IV | 34 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Post-Operative Pathological Stage Response | Stage 0 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Post-Operative Pathological Stage Response | Stage IV | 5 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Post-Operative Pathological Stage Response | Stage 0 | 23 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Post-Operative Pathological Stage Response | Stage IA | 32 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Post-Operative Pathological Stage Response | Stage IB | 23 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Post-Operative Pathological Stage Response | Stage IIA | 47 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Post-Operative Pathological Stage Response | Stage IIB | 36 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Post-Operative Pathological Stage Response | Stage IIIA | 18 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Post-Operative Pathological Stage Response | Stage IIIB | 24 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Post-Operative Pathological Stage Response | Stage IIIC | 14 Participants |
Secondary
Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3
NCI-CTCAE version 4.03 was used to determine Gr, where Gr refers to severity of AE: Gr 1:mild; asymptomatic/mild symptoms; Gr 2:moderate; minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Aspartate and alanine aminotransferase increased were based on Gr1: \>ULN-3.0\*ULN; Gr2: \>3.0-5.0\*ULN; Gr3: \>5.0-20.0\*ULN; Gr4: \>20.0\*ULN. Blood bilirubin increased: Gr1: \>ULN-1.5\*ULN; Gr2 \>1.5-3.0\*ULN; Gr3: \>3.0-10.0\*ULN; Gr4: \>10.0\*ULN. Alkaline phosphatase increased: Gr1: \>ULN-2.5\*ULN; Gr2: \>2.5-5.0\*ULN; Gr3: \>5.0-20.0\*ULN; Gr4: \>20.0\*ULN. Glucose (Hypoglycemia): Gr 1: \<LLN-55 mg/dL; Gr2: \<55-40 mg/dL;Gr3: \<40-30 mg/dL; Gr4: \<30 mg/dL; Gr5:Death. Glucose (Hyperglycemia): Gr 1: Fasting glucose value \>ULN-160 mg/dL; Gr2: Fasting glucose value \>160-250 mg/dL; Gr3: \>250-500 mg/dL; Gr4: \>500 mg/dL; Gr5: Death.
Time frame: From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years)
Population: Analysis was performed on safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alkaline phosphatase Gr 0 at Baseline to Gr >=3 | 3 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Aspartate aminotransferase Gr5 at Baseline toGr>=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alkaline phosphatase Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alanine aminotransferase Gr4 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alkaline phosphatase Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Aspartate aminotransferase Gr3 at Baseline toGr>=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alkaline phosphatase Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alanine aminotransferase Gr5 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alkaline phosphatase Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alanine aminotransferase Gr0 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alkaline phosphatase Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Bilirubin increased Gr 0 at Baseline to Gr >=3 | 2 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoglycemia Gr 0 at Baseline to Gr >=3 | 4 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Aspartate aminotransferase Gr2 at Baseline toGr>=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoglycemia Gr 1 at Baseline to Gr >=3 | 1 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Bilirubin increased Gr 1 at Baseline to Gr >=3 | 1 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoglycemia Gr 2 at Baseline to Gr >=3 | 1 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alanine aminotransferase Gr1 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoglycemia Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Bilirubin increased Gr 2 at Baseline to Gr >=3 | 1 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoglycemia Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Aspartate aminotransferase Gr4 at Baseline toGr>=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoglycemia Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Bilirubin increased Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperglycemia Gr 0 at Baseline to Gr >=3 | 4 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alanine aminotransferase Gr2 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperglycemia Gr 1 at Baseline to Gr >=3 | 13 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Bilirubin increased Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperglycemia Gr 2 at Baseline to Gr >=3 | 2 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Aspartate aminotransferase Gr1 at Baseline toGr>=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperglycemia Gr 3 at Baseline to Gr >=3 | 3 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Bilirubin increased Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperglycemia Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alanine aminotransferase Gr3 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperglycemia Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Aspartate aminotransferase Gr0 at Baseline toGr>=3 | 1 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperglycemia Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Aspartate aminotransferase Gr0 at Baseline toGr>=3 | 1 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Aspartate aminotransferase Gr1 at Baseline toGr>=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Aspartate aminotransferase Gr2 at Baseline toGr>=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Aspartate aminotransferase Gr3 at Baseline toGr>=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Aspartate aminotransferase Gr4 at Baseline toGr>=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Aspartate aminotransferase Gr5 at Baseline toGr>=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alanine aminotransferase Gr0 at Baseline to Gr >=3 | 1 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alanine aminotransferase Gr1 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alanine aminotransferase Gr2 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alanine aminotransferase Gr3 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alanine aminotransferase Gr4 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alanine aminotransferase Gr5 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Bilirubin increased Gr 0 at Baseline to Gr >=3 | 4 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Bilirubin increased Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Bilirubin increased Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Bilirubin increased Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Bilirubin increased Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Bilirubin increased Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alkaline phosphatase Gr 0 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alkaline phosphatase Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alkaline phosphatase Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alkaline phosphatase Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alkaline phosphatase Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Alkaline phosphatase Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoglycemia Gr 0 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoglycemia Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoglycemia Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoglycemia Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoglycemia Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoglycemia Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperglycemia Gr 0 at Baseline to Gr >=3 | 12 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperglycemia Gr 1 at Baseline to Gr >=3 | 13 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperglycemia Gr 2 at Baseline to Gr >=3 | 10 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperglycemia Gr 3 at Baseline to Gr >=3 | 2 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperglycemia Gr 4 at Baseline to Gr >=3 | 0 Participants |
Secondary
Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3
NCI-CTCAE version 4.03 was used to determine Gr,where Gr refers to severity of AE:Gr 1:mild; asymptomatic/mild symptoms; Gr 2:moderate;minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Calcium(Hypocalcemia) were based on Gr1: Corrected serum calcium of \<LLN-8.0 mg/dL; Gr2: Corrected serum calcium of \<8.0-7.0 mg/dL; Gr3: Corrected serum calcium of \<7.0-6.0 mg/dL ; Gr4: Corrected serum calcium of \<6.0 mg/dL;Gr5:death. Calcium(Hypercalcemia):Gr 1: Corrected serum calcium of \>ULN -11.5 mg/dL; Gr2: Corrected serum calcium of \>11.5-12.5 mg/dL; Gr3: Corrected serum calcium of \>12.5-13.5 mg/dL; Gr4: Corrected serum calcium of \>13.5 mg/dL;Gr5:Death. Creatinine increased: Gr 1: \>1-1.5\*baseline; \>ULN-1.5\*ULN; Gr2: \>1.5-3.0\*baseline; \>1.5-3.0\*ULN; Gr3: \>3.0 baseline; \>3.0-6.0\*ULN; Gr4: \>6.0 x ULN. Albumin(Hypoalbuminemia): Gr 1: \<LLN-3 g/dL; Gr2: \<3-2 g/dL; Gr3: \<2 g/dL; Gr4:life-threatening consequences;Gr5:Death.
Time frame: From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years)
Population: Analysis was performed on safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypercalcemia Gr 0 at Baseline to Gr >=3 | 1 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypocalcemia Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypocalcemia Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypocalcemia Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypocalcemia Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypocalcemia Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypocalcemia Gr 0 at Baseline to Gr >=3 | 1 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypercalcemia Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypercalcemia Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypercalcemia Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypercalcemia Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypercalcemia Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Creatinine increased Gr 0 at Baseline to Gr >=3 | 4 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Creatinine increased Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Creatinine increased Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Creatinine increased Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Creatinine increased Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Creatinine increased Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoalbuminemia Gr 0 at Baseline to Gr >=3 | 1 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoalbuminemia Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoalbuminemia Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoalbuminemia Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoalbuminemia Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoalbuminemia Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoalbuminemia Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypocalcemia Gr 0 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Creatinine increased Gr 0 at Baseline to Gr >=3 | 8 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypocalcemia Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoalbuminemia Gr 0 at Baseline to Gr >=3 | 2 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypocalcemia Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Creatinine increased Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypocalcemia Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoalbuminemia Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypocalcemia Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Creatinine increased Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypocalcemia Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoalbuminemia Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypercalcemia Gr 0 at Baseline to Gr >=3 | 1 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Creatinine increased Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypercalcemia Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoalbuminemia Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypercalcemia Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Creatinine increased Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypercalcemia Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypoalbuminemia Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypercalcemia Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Creatinine increased Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypercalcemia Gr 5 at Baseline to Gr >=3 | 0 Participants |
Secondary
Number of Participants With Shift of Laboratory Parameters (Creatinine Clearance [Chronic Kidney Disease]) From Baseline Grade to Worst NCI-CTCAE Grade >=3
NCI-CTCAE version 4.03 was used to determine Gr, where Gr refers to severity of AE: Gr 1: mild; asymptomatic/mild symptoms; Gr 2: moderate; minimal; Gr 3: severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Creatinine Clearance(Chronic kidney disease) were based on: Gr 1: estimated glomerular filtration rate (eGFR) or creatinine clearance (CrCl) \<LLN-60ml/min/1.73 m\^2; Gr2: eGFR or CrCl 59-30 ml/min/1.73 m\^2; Gr3: eGFR or CrCl 29-15 ml/min/1.73 m\^2; Gr4: eGFR or CrCl \<15 ml/min/1.73 m\^2; Gr5: Death.
Time frame: From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years)
Population: Analysis was performed on safety population. Data was planned to be collected and analyzed for Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) arm only.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Creatinine Clearance [Chronic Kidney Disease]) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Creatinine Clearance Gr 0 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Creatinine Clearance [Chronic Kidney Disease]) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Creatinine Clearance Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Creatinine Clearance [Chronic Kidney Disease]) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Creatinine Clearance Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Creatinine Clearance [Chronic Kidney Disease]) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Creatinine Clearance Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Creatinine Clearance [Chronic Kidney Disease]) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Creatinine Clearance Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Creatinine Clearance [Chronic Kidney Disease]) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Creatinine Clearance Gr 5 at Baseline to Gr >=3 | 0 Participants |
Secondary
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3
NCI-CTCAE version 4.03 was used to determine Grade(Gr),where Gr refers to severity of AE:Gr 1:mild; asymptomatic/mild symptoms; Gr 2:moderate;minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Hemoglobin(Hb)(Anemia) were based on Gr1:\<lower limit of normal (LLN)-10.0g/dL; Gr2:\<10.0-8.0g/dL; Gr3:\<8.0g/dL; Gr4:life-threatening consequences;Gr5:death. Hb increased:Gr 1:increase(incr.) in \>0-2g/dL above upper limit of normal(ULN);Gr2: incr. in \>2-4g/dL above ULN; Gr3:incr. in \>4gm/dL above ULN. White blood cell (WBC) decreased: Gr1:\<LLN - 3000/mm\^3;Gr2: \<3000-2000/mm\^3; Gr3:\<2000-1000/mm\^3;Gr4:\<1000/mm\^3. WBC (Leukocytosis):Gr3:\>100,000/mm\^3, Gr4:clinical manifestations of leucostasis;Gr5:Death. Abnormal Neutrophil count (ANC):- Gr1:\<LLN-1500/mm\^3;Gr2:\<1500-1000/mm\^3; Gr3: \<1000-500/mm\^3; Gr4:\<500/mm\^3. Platelet count decreased: Gr1:\<LLN-75,000/mm\^3;Gr2:\<75,000-50,000/mm\^3;Gr3:\<50,000-25,000/mm\^3;Gr4:\<25,000/mm\^3.
Time frame: From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years)
Population: Analysis was performed on safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | ANC Gr 0 at Baseline to Gr >=3 | 14 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb(Anemia) Gr 0 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb(Anemia) Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb(Anemia) Gr 2 at Baseline to Gr >=3 | 1 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb(Anemia) Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb(Anemia) Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb(Anemia) Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb increased Gr 0 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb increased Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb increased Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb increased Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb increased Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb increased Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC decreased Gr 0 at Baseline to Gr >=3 | 1 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC decreased Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC decreased Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC decreased Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC decreased Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC decreased Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC (Leukocytosis) Gr 0 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC (Leukocytosis) Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC (Leukocytosis) Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC (Leukocytosis) Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC (Leukocytosis) Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC (Leukocytosis) Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | ANC Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | ANC Gr 2 at Baseline to Gr >=3 | 1 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | ANC Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | ANC Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | ANC Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Platelet count decreased Gr0 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Platelet count decreased Gr1 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Platelet count decreased Gr2 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Platelet count decreased Gr3 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Platelet count decreased Gr4 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Platelet count decreased Gr5 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC decreased Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | ANC Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb(Anemia) Gr 0 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC (Leukocytosis) Gr 0 at Baseline to Gr >=3 | 1 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb(Anemia) Gr 1 at Baseline to Gr >=3 | 4 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Platelet count decreased Gr5 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb(Anemia) Gr 2 at Baseline to Gr >=3 | 1 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC (Leukocytosis) Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb(Anemia) Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | ANC Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb(Anemia) Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC (Leukocytosis) Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb(Anemia) Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Platelet count decreased Gr2 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb increased Gr 0 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC (Leukocytosis) Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb increased Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | ANC Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb increased Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC (Leukocytosis) Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb increased Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Platelet count decreased Gr4 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb increased Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC (Leukocytosis) Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Hb increased Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | ANC Gr 0 at Baseline to Gr >=3 | 40 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC decreased Gr 0 at Baseline to Gr >=3 | 8 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Platelet count decreased Gr0 at Baseline to Gr >=3 | 5 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC decreased Gr 1 at Baseline to Gr >=3 | 1 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | ANC Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC decreased Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Platelet count decreased Gr3 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC decreased Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | ANC Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | WBC decreased Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | Platelet count decreased Gr1 at Baseline to Gr >=3 | 0 Participants |
Secondary
Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3
NCI-CTCAE version 4.03 was used to determine Gr,where Gr refers to severity of AE: Gr 1: mild; asymptomatic/mild symptoms; Gr 2: moderate; minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Sodium (Hyponatremia) were based on Gr1: \<LLN-130 mmol/L; Gr3: \<130-120 mmol/L; Gr4: \<120 mmol/L; life-threatening consequences; Gr5: death. Sodium (Hypernatremia):Gr 1: \>ULN-150 mmol/L; Gr2: \>150-155 mmol/L; Gr3:\>155-160 mmol/L;hospitalization; Gr4: \>160 mmol/L; life-threatening consequences; Gr5: Death. Potassium (Hypokalemia): Gr 1: \<LLN-3.0 mmol/L; Gr2: \<LLN-3.0 mmol/L; symptomatic; intervention indicated; Gr3: \<3.0-2.5 mmol/L; hospitalization indicated; Gr4: \<2.5 mmol/L; life-threatening consequences; Gr5: Death; Potassium(Hyperkalemia): Gr 1: \>ULN-5.5 mmol/L; Gr2: \>5.5-6.0 mmol/L; Gr3: \>6.0-7.0 mmol/L; hospitalization indicated; Gr4: \>7.0 mmol/L; life-threatening consequences; Gr5: Death.
Time frame: From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years)
Population: Analysis was performed on safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypernatremia Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyponatremia Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyponatremia Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyponatremia Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypernatremia Gr 0 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypernatremia Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyponatremia Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypernatremia Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypernatremia Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypernatremia Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypokalemia Gr 0 at Baseline to Gr >=3 | 1 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypokalemia Gr 1 at Baseline to Gr >=3 | 1 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypokalemia Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypokalemia Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypokalemia Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypokalemia Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperkalemia Gr 0 at Baseline to Gr >=3 | 1 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperkalemia Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperkalemia Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperkalemia Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperkalemia Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperkalemia Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyponatremia Gr 0 at Baseline to Gr >=3 | 1 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyponatremia Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyponatremia Gr 0 at Baseline to Gr >=3 | 7 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyponatremia Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypokalemia Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyponatremia Gr 3 at Baseline to Gr >=3 | 1 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperkalemia Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyponatremia Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypokalemia Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyponatremia Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperkalemia Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypernatremia Gr 0 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypokalemia Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypernatremia Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperkalemia Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypernatremia Gr 2 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypokalemia Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypernatremia Gr 3 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyponatremia Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypernatremia Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperkalemia Gr 0 at Baseline to Gr >=3 | 4 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypernatremia Gr 5 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperkalemia Gr 4 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypokalemia Gr 0 at Baseline to Gr >=3 | 2 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hyperkalemia Gr 1 at Baseline to Gr >=3 | 0 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | Hypokalemia Gr 1 at Baseline to Gr >=3 | 1 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs were defined as adverse events (AE) that appeared or worsened during the treatment period (up to 30 days after the last dose of the investigational product). SAE was an AE or adverse drug reaction at any dose of the investigational product that corresponded to one of the following: resulting in death or is life threatening; requiring in-patient hospitalization or prolongation of existing hospitalization; resulting in persistent or significant disability of dysfunction; resulting in congenital anomaly or birth defect; important medical event.
Time frame: From randomization up to 30 days after last dose of study drug (maximum duration: up to 10 years)
Population: Analysis was performed on safety population which included participants who were administered at least one dose of the investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Any TEAE | 190 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Any treatment emergent SAE | 57 Participants |
| Surgery + Adjuvant Chemotherapy (SC) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs leading to permanent discontinuation | 11 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Any TEAE | 237 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Any treatment emergent SAE | 102 Participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs leading to permanent discontinuation | 25 Participants |
Secondary
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. Analyzed using Kaplan-Meier method.
Time frame: From randomization to date of death due to any cause (maximum duration: up to 10 years)
Population: Analysis was performed on FAS population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Surgery + Adjuvant Chemotherapy (SC) | Overall Survival (OS) | NA months |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Overall Survival (OS) | NA months |
Secondary
Percentage of Participants With R0 Resection
Tumor condition was explained according to the Residual Tumor (R) Classification: R0; No residual cancer (negative cross-section), R1; Microscopically observed residual cancer (positive cross-section), R2; Macroscopically observed residual cancer.
Time frame: Up to 10 years
Population: Analysis was performed on FAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Surgery + Adjuvant Chemotherapy (SC) | Percentage of Participants With R0 Resection | 83.74 percentage of participants |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Percentage of Participants With R0 Resection | 95.50 percentage of participants |