Trial Outcomes & Findings for Perioperative Treatment in Resectable Gastric Cancer With Spartalizumab (PDR001) in Combination With Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel (FLOT) (NCT NCT04736485)
NCT ID: NCT04736485
Last Updated: 2026-05-08
Results Overview
Proportion of patients with pCR (pathologic complete response) in the primary tumour defined as: no tumour residue found in the tissue collected during the surgery evaluated by the pathologist. For the primary objective, the pathologic response after pre-operative treatment will be assessed by the local experienced pathologists. Tumour regression grade will be quantified using the Becker regression criteria, which are based on the estimation of the percentage of vital tumour cells in relation to the macroscopically identifiable tumour bed and include the following categories: * TRG1a (equivalent to pathological complete regression; no residual tumour cells); * TRG1b (subtotal regression; \<10% residual tumour cells); * TRG2 (partial regression; 10-50% residual tumour cells); and * TRG3 (minor or no regression; \>50% residual tumour cells).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
At surgery, an average 3 months after treatment initiation
Results posted on
2026-05-08
Participant Flow
Participant milestones
| Measure |
Experimental Arm
Treatment :
\- Standard FLOT regimen administered every two weeks for 4 pre-operative cycles (8 weeks) and 4 post-operative cycles (8 weeks) : Docétaxel 50mg/m2 IV infusion on D1 Oxaliplatine 85mg/m2 IV infusion on D1 Leucovorin 200 mg/m2 IV infusion on D1 Fluorouracile 2600 mg/m2 IV infusion on D1
\- Spartalizumab at fixed dose of 400 mg per IV infusion over 30 minutes on D1 every four weeks for 2 pre-operative cycles (8 weeks) and 2 post-operative cycles (8 weeks).
|
|---|---|
|
Overall Study
STARTED
|
67
|
|
Overall Study
COMPLETED
|
67
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental Arm
n=67 Participants
Treatment :
\- Standard FLOT regimen administered every two weeks for 4 pre-operative cycles (8 weeks) and 4 post-operative cycles (8 weeks) : Docétaxel 50mg/m2 IV infusion on D1 Oxaliplatine 85mg/m2 IV infusion on D1 Leucovorin 200 mg/m2 IV infusion on D1 Fluorouracile 2600 mg/m2 IV infusion on D1
\- Spartalizumab at fixed dose of 400 mg per IV infusion over 30 minutes on D1 every four weeks for 2 pre-operative cycles (8 weeks) and 2 post-operative cycles (8 weeks).
|
|---|---|
|
Age, Continuous
|
62 year
STANDARD_DEVIATION 11 • n=67 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=67 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=67 Participants
|
|
ECOG
0 : Fully active, able to carry on all pre-disease activities without restriction
|
46 Participants
n=67 Participants
|
|
ECOG
1 : Restricted in physically strenuous activity but ambulatory and able to carry out light work
|
21 Participants
n=67 Participants
|
PRIMARY outcome
Timeframe: At surgery, an average 3 months after treatment initiationPopulation: 2 patients without surgery and 1 not eligible because of T1N0 disease
Proportion of patients with pCR (pathologic complete response) in the primary tumour defined as: no tumour residue found in the tissue collected during the surgery evaluated by the pathologist. For the primary objective, the pathologic response after pre-operative treatment will be assessed by the local experienced pathologists. Tumour regression grade will be quantified using the Becker regression criteria, which are based on the estimation of the percentage of vital tumour cells in relation to the macroscopically identifiable tumour bed and include the following categories: * TRG1a (equivalent to pathological complete regression; no residual tumour cells); * TRG1b (subtotal regression; \<10% residual tumour cells); * TRG2 (partial regression; 10-50% residual tumour cells); and * TRG3 (minor or no regression; \>50% residual tumour cells).
Outcome measures
| Measure |
Experimental Arm
n=64 Participants
Treatment :
\- Standard FLOT regimen administered every two weeks for 4 pre-operative cycles (8 weeks) and 4 post-operative cycles (8 weeks) : Docétaxel 50mg/m2 IV infusion on D1 Oxaliplatine 85mg/m2 IV infusion on D1 Leucovorin 200 mg/m2 IV infusion on D1 Fluorouracile 2600 mg/m2 IV infusion on D1
\- Spartalizumab at fixed dose of 400 mg per IV infusion over 30 minutes on D1 every four weeks for 2 pre-operative cycles (8 weeks) and 2 post-operative cycles (8 weeks).
|
|---|---|
|
Pathologic Response After Pre-operative Treatment
|
20 Participants
|
SECONDARY outcome
Timeframe: 24 months after study enrollmentDisease-free survival (DFS) defined as time between inclusion and first disease progression. Disease was assessed locally according to RECIST v1.1 (Response Evaluation Criteria in solid Tumors) criteria.
Outcome measures
| Measure |
Experimental Arm
n=67 Participants
Treatment :
\- Standard FLOT regimen administered every two weeks for 4 pre-operative cycles (8 weeks) and 4 post-operative cycles (8 weeks) : Docétaxel 50mg/m2 IV infusion on D1 Oxaliplatine 85mg/m2 IV infusion on D1 Leucovorin 200 mg/m2 IV infusion on D1 Fluorouracile 2600 mg/m2 IV infusion on D1
\- Spartalizumab at fixed dose of 400 mg per IV infusion over 30 minutes on D1 every four weeks for 2 pre-operative cycles (8 weeks) and 2 post-operative cycles (8 weeks).
|
|---|---|
|
Evaluate the Impact of Perioperative Treatment on Disease-free Survival
|
NA month
Median not reached. Insufficient number of events observed.
|
SECONDARY outcome
Timeframe: 24 months after enrollmentOverall survival (OS) defined as the time between inclusion and death whatever cause;
Outcome measures
| Measure |
Experimental Arm
n=67 Participants
Treatment :
\- Standard FLOT regimen administered every two weeks for 4 pre-operative cycles (8 weeks) and 4 post-operative cycles (8 weeks) : Docétaxel 50mg/m2 IV infusion on D1 Oxaliplatine 85mg/m2 IV infusion on D1 Leucovorin 200 mg/m2 IV infusion on D1 Fluorouracile 2600 mg/m2 IV infusion on D1
\- Spartalizumab at fixed dose of 400 mg per IV infusion over 30 minutes on D1 every four weeks for 2 pre-operative cycles (8 weeks) and 2 post-operative cycles (8 weeks).
|
|---|---|
|
Evaluate the Impact of Perioperative Treatment on Overall Survival
|
NA month
median OS not reached. Not enough events observed to compute median OS time.
|
SECONDARY outcome
Timeframe: At surgery, an average 3 months after treatment initiationPopulation: Surgery was performed in 65 patients (97%).
Proportion of patients with margin-free resection (R0), defined as a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed
Outcome measures
| Measure |
Experimental Arm
n=65 Participants
Treatment :
\- Standard FLOT regimen administered every two weeks for 4 pre-operative cycles (8 weeks) and 4 post-operative cycles (8 weeks) : Docétaxel 50mg/m2 IV infusion on D1 Oxaliplatine 85mg/m2 IV infusion on D1 Leucovorin 200 mg/m2 IV infusion on D1 Fluorouracile 2600 mg/m2 IV infusion on D1
\- Spartalizumab at fixed dose of 400 mg per IV infusion over 30 minutes on D1 every four weeks for 2 pre-operative cycles (8 weeks) and 2 post-operative cycles (8 weeks).
|
|---|---|
|
The Correlation Between Pathologic Complete Response and Survival Outcomes (Disease-free and Overall Survival)
|
61 Participants
|
SECONDARY outcome
Timeframe: Toxicities occurring up to 1 month after the end of treatmentType, grade and number of Adverse Events as Assessed by CTCAE v5.0
Outcome measures
| Measure |
Experimental Arm
n=67 Participants
Treatment :
\- Standard FLOT regimen administered every two weeks for 4 pre-operative cycles (8 weeks) and 4 post-operative cycles (8 weeks) : Docétaxel 50mg/m2 IV infusion on D1 Oxaliplatine 85mg/m2 IV infusion on D1 Leucovorin 200 mg/m2 IV infusion on D1 Fluorouracile 2600 mg/m2 IV infusion on D1
\- Spartalizumab at fixed dose of 400 mg per IV infusion over 30 minutes on D1 every four weeks for 2 pre-operative cycles (8 weeks) and 2 post-operative cycles (8 weeks).
|
|---|---|
|
Treatment-Related Adverse Events
|
67 Participants
|
Adverse Events
Experimental Arm
Serious events: 50 serious events
Other events: 67 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Experimental Arm
n=67 participants at risk
Treatment :
\- Standard FLOT regimen administered every two weeks for 4 pre-operative cycles (8 weeks) and 4 post-operative cycles (8 weeks) : Docétaxel 50mg/m2 IV infusion on D1 Oxaliplatine 85mg/m2 IV infusion on D1 Leucovorin 200 mg/m2 IV infusion on D1 Fluorouracile 2600 mg/m2 IV infusion on D1
\- Spartalizumab at fixed dose of 400 mg per IV infusion over 30 minutes on D1 every four weeks for 2 pre-operative cycles (8 weeks) and 2 post-operative cycles (8 weeks).
|
|---|---|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
URTICARIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
IMMUNE SYSTEM DISORDERS
DRUG HYPERSENSITIVITY
|
7.5%
5/67 • Number of events 6 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
UPPER GASTROINTESTINAL HAEMORRHAGE
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
PANCREATITIS ACUTE
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
SUBILEUS
|
6.0%
4/67 • Number of events 4 • Up to 24 months after enrollment
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
ANASTOMOTIC FISTULA
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PLEURAL EFFUSION
|
4.5%
3/67 • Number of events 3 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
ACUTE RESPIRATORY DISTRESS SYNDROME
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
VASCULAR DISORDERS
DEEP VEIN THROMBOSIS
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
PRODUCT ISSUES
DEVICE LEAKAGE
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
GENERAL PHYSICAL HEALTH DETERIORATION
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
CONGENITAL, FAMILIAL AND GENETIC DISORDERS
APLASIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
PNEUMONIA
|
4.5%
3/67 • Number of events 3 • Up to 24 months after enrollment
|
|
METABOLISM AND NUTRITION DISORDERS
HYPOKALAEMIA
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
HAEMATEMESIS
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
NERVOUS SYSTEM DISORDERS
IMMUNE-MEDIATED ENCEPHALITIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
IMMUNE SYSTEM DISORDERS
ANAPHYLACTIC SHOCK
|
6.0%
4/67 • Number of events 5 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
DYSPHAGIA
|
4.5%
3/67 • Number of events 3 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
COVID-19
|
4.5%
3/67 • Number of events 4 • Up to 24 months after enrollment
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
CHEST PAIN
|
4.5%
3/67 • Number of events 3 • Up to 24 months after enrollment
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MEDICAL DEVICE SITE THROMBOSIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
PNEUMONIA NECROTISING
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
METABOLISM AND NUTRITION DISORDERS
HYPERGLYCAEMIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
SEPSIS
|
7.5%
5/67 • Number of events 5 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
HIATUS HERNIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
ATELECTASIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PNEUMOTHORAX
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
PNEUMOPERITONEUM
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
TOXIC SKIN ERUPTION
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
NEUTROPENIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PYREXIA
|
4.5%
3/67 • Number of events 4 • Up to 24 months after enrollment
|
|
HEPATOBILIARY DISORDERS
HEPATIC CYTOLYSIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RENAL AND URINARY DISORDERS
FANCONI SYNDROME ACQUIRED
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INVESTIGATIONS
ELECTROCARDIOGRAM QT PROLONGED
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
ENDOCRINE DISORDERS
HYPOTHYROIDISM
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RENAL AND URINARY DISORDERS
NEPHRITIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
DYSPNOEA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
COUGH
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
VOMITING
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
NAUSEA
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
SMALL INTESTINAL OBSTRUCTION
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
PEMPHIGOID
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
CATHETER SITE THROMBOSIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
STAPHYLOCOCCAL SEPSIS
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
DIARRHOEA
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
NERVOUS SYSTEM DISORDERS
DIZZINESS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
HEPATOBILIARY DISORDERS
IMMUNE-MEDIATED HEPATITIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RENAL AND URINARY DISORDERS
ACUTE KIDNEY INJURY
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
PALPABLE PURPURA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
RASH MACULO-PAPULAR
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
HEPATOBILIARY DISORDERS
CHOLESTASIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
NEOPLASM MALIGNANT
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
SEPTIC SHOCK
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
NERVOUS SYSTEM DISORDERS
TRANSIENT ISCHAEMIC ATTACK
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
ENTEROBACTER INFECTION
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
PANCREATITIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
DUMPING SYNDROME
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
METABOLISM AND NUTRITION DISORDERS
MALNUTRITION
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
LUNG DISORDER
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
FEBRILE BONE MARROW APLASIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
IMMUNE SYSTEM DISORDERS
HYPERSENSITIVITY
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
BRONCHIAL CARCINOMA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
IMMUNE-MEDIATED ENTEROCOLITIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
IMPLANT SITE INFECTION
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
STOMA SITE ABSCESS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PULMONARY EMBOLISM
|
4.5%
3/67 • Number of events 3 • Up to 24 months after enrollment
|
|
RENAL AND URINARY DISORDERS
RENAL FAILURE
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
HAEMATOMA MUSCLE
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
OESOPHAGOBRONCHIAL FISTULA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
INGUINAL HERNIA, OBSTRUCTIVE
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
HERNIAL EVENTRATION
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
GASTROINTESTINAL ANASTOMOTIC STENOSIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
HYPOXIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
NERVOUS SYSTEM DISORDERS
NEUROTOXICITY
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
OESOPHAGEAL STENOSIS
|
1.5%
1/67 • Number of events 5 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
ESCHERICHIA SEPSIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
HAEMATOCHEZIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
LOWER GASTROINTESTINAL HAEMORRHAGE
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
ILEUS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MUCOSAL INFLAMMATION
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
FISTULA OF SMALL INTESTINE
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
ANASTOMOTIC STENOSIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RENAL AND URINARY DISORDERS
URINARY BLADDER TOXICITY
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
HYPERTHERMIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
COLONIC ABSCESS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
DIVERTICULITIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
TOXIC EPIDERMAL NECROLYSIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
METABOLISM AND NUTRITION DISORDERS
TYPE 1 DIABETES MELLITUS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
PNEUMOCYSTIS JIROVECII PNEUMONIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
Other adverse events
| Measure |
Experimental Arm
n=67 participants at risk
Treatment :
\- Standard FLOT regimen administered every two weeks for 4 pre-operative cycles (8 weeks) and 4 post-operative cycles (8 weeks) : Docétaxel 50mg/m2 IV infusion on D1 Oxaliplatine 85mg/m2 IV infusion on D1 Leucovorin 200 mg/m2 IV infusion on D1 Fluorouracile 2600 mg/m2 IV infusion on D1
\- Spartalizumab at fixed dose of 400 mg per IV infusion over 30 minutes on D1 every four weeks for 2 pre-operative cycles (8 weeks) and 2 post-operative cycles (8 weeks).
|
|---|---|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
GAIT DISTURBANCE
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
OVERGROWTH BACTERIAL
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
VAGINAL HAEMORRHAGE
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL DISCOMFORT
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
OROPHARYNGEAL CANDIDIASIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
GENERAL PHYSICAL HEALTH DETERIORATION
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
BACTERIAL INFECTION
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
PYELONEPHRITIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
HEPATOBILIARY DISORDERS
CHOLELITHIASIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
NERVOUS SYSTEM DISORDERS
NEUROMUSCULAR BLOCKADE
|
1.5%
1/67 • Number of events 3 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
RESPIRATORY FAILURE
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
SEPTIC SHOCK
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
METABOLISM AND NUTRITION DISORDERS
FOOD INTOLERANCE
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
LYMPHADENOPATHY
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
SPINAL PAIN
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
HYPERAESTHESIA TEETH
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
EYE DISORDERS
VISUAL IMPAIRMENT
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
HEPATOBILIARY DISORDERS
IMMUNE-MEDIATED HEPATIC DISORDER
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RENAL AND URINARY DISORDERS
ACUTE KIDNEY INJURY
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
METABOLISM AND NUTRITION DISORDERS
DIABETES MELLITUS INADEQUATE CONTROL
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
SKIN BURNING SENSATION
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
CARDIAC DISORDERS
ANGINA PECTORIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
NERVOUS SYSTEM DISORDERS
COLD DYSAESTHESIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RENAL AND URINARY DISORDERS
LEUKOCYTURIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RENAL AND URINARY DISORDERS
DYSURIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RENAL AND URINARY DISORDERS
POLLAKIURIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
VASCULAR DISORDERS
HAEMORRHAGE
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
NERVOUS SYSTEM DISORDERS
NEURALGIA
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
METABOLISM AND NUTRITION DISORDERS
GOUT
|
1.5%
1/67 • Number of events 2 • Up to 24 months after enrollment
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
SKIN EXFOLIATION
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
RASH MACULO-PAPULAR
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
HAEMATEMESIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
OESOPHAGEAL ULCER
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
LARYNGEAL DISCOMFORT
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
VASCULAR DISORDERS
HYPOTENSION
|
6.0%
4/67 • Number of events 4 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
LUNG DISORDER
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
DRY MOUTH
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
NASAL DRYNESS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
CONJUNCTIVITIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
METABOLISM AND NUTRITION DISORDERS
TYPE 2 DIABETES MELLITUS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INVESTIGATIONS
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
RENAL AND URINARY DISORDERS
URETERIC STENOSIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
ENTEROCOCCAL INFECTION
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
VULVOVAGINAL INFLAMMATION
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INVESTIGATIONS
INTERNATIONAL NORMALISED RATIO INCREASED
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
OESOPHAGEAL CANDIDIASIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
PSYCHIATRIC DISORDERS
INSOMNIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
PETECHIAE
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
CARDIAC DISORDERS
ATRIAL FIBRILLATION
|
3.0%
2/67 • Number of events 3 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
ABSCESS INTESTINAL
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
NERVOUS SYSTEM DISORDERS
AGEUSIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
RESPIRATORY DISTRESS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RENAL AND URINARY DISORDERS
RENAL FAILURE
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
ENDOCRINE DISORDERS
HYPOTHYROIDISM
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
OESOPHAGEAL PAIN
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
SUBDIAPHRAGMATIC ABSCESS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
PANCREATIC FAILURE
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL DISTENSION
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
METABOLISM AND NUTRITION DISORDERS
HYPONATRAEMIA
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
CARDIAC DISORDERS
TACHYCARDIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
PROCEDURAL NAUSEA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
SINUSITIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
SALIVA ALTERED
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
METABOLISM AND NUTRITION DISORDERS
CELL DEATH
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
IMMUNE SYSTEM DISORDERS
DRUG HYPERSENSITIVITY
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
VASCULAR DISORDERS
BRACHIOCEPHALIC VEIN THROMBOSIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
MUCOCUTANEOUS TOXICITY
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
COUGH
|
10.4%
7/67 • Number of events 8 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PULMONARY EMBOLISM
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
NERVOUS SYSTEM DISORDERS
PERIPHERAL SENSORY NEUROPATHY
|
6.0%
4/67 • Number of events 4 • Up to 24 months after enrollment
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MUCOSAL INFLAMMATION
|
22.4%
15/67 • Number of events 16 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
ACUTE RESPIRATORY FAILURE
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
PNEUMONIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PAIN
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
DERMATITIS ALLERGIC
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INVESTIGATIONS
ASPARTATE AMINOTRANSFERASE INCREASED
|
6.0%
4/67 • Number of events 4 • Up to 24 months after enrollment
|
|
INVESTIGATIONS
ALANINE AMINOTRANSFERASE INCREASED
|
7.5%
5/67 • Number of events 5 • Up to 24 months after enrollment
|
|
IMMUNE SYSTEM DISORDERS
HYPERSENSITIVITY
|
4.5%
3/67 • Number of events 3 • Up to 24 months after enrollment
|
|
METABOLISM AND NUTRITION DISORDERS
HYPOMAGNESAEMIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
ANASTOMOTIC FISTULA
|
4.5%
3/67 • Number of events 3 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
IMPLANT SITE INFECTION
|
6.0%
4/67 • Number of events 4 • Up to 24 months after enrollment
|
|
INVESTIGATIONS
ALANINE AMINOTRANSFERASE ABNORMAL
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
METABOLISM AND NUTRITION DISORDERS
HYPERKALAEMIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
STAPHYLOCOCCAL INFECTION
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
APHTHOUS ULCER
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
THROMBOCYTOPENIA
|
13.4%
9/67 • Number of events 10 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
DYSPEPSIA
|
4.5%
3/67 • Number of events 3 • Up to 24 months after enrollment
|
|
ENDOCRINE DISORDERS
HYPERTHYROIDISM
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
ERYTHEMA
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
URTICARIA
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
BONE PAIN
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
IMMUNE SYSTEM DISORDERS
CONTRAST MEDIA ALLERGY
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
METABOLISM AND NUTRITION DISORDERS
STARVATION
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
PRURITUS
|
11.9%
8/67 • Number of events 9 • Up to 24 months after enrollment
|
|
INVESTIGATIONS
LIVER FUNCTION TEST ABNORMAL
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
STOMATITIS
|
4.5%
3/67 • Number of events 4 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
GASTROOESOPHAGEAL REFLUX DISEASE
|
10.4%
7/67 • Number of events 8 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
DYSPHAGIA
|
10.4%
7/67 • Number of events 8 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
EPISTAXIS
|
9.0%
6/67 • Number of events 6 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
INTESTINAL OBSTRUCTION
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
ACTINIC KERATOSIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
SALIVARY HYPERSECRETION
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
DYSPHONIA
|
4.5%
3/67 • Number of events 3 • Up to 24 months after enrollment
|
|
NERVOUS SYSTEM DISORDERS
COGNITIVE DISORDER
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
METABOLISM AND NUTRITION DISORDERS
HYPERGLYCAEMIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
DYSPNOEA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
INFECTION
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
NAIL DISORDER
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
NERVOUS SYSTEM DISORDERS
PAROSMIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
PNEUMONIA ASPIRATION
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
ACUTE RESPIRATORY DISTRESS SYNDROME
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
VASCULAR DISORDERS
VENA CAVA THROMBOSIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
PYLOROSPASM
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
METABOLISM AND NUTRITION DISORDERS
MALNUTRITION
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
COVID-19
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
RECTAL HAEMORRHAGE
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
TENDONITIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
EAR AND LABYRINTH DISORDERS
EAR PAIN
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
ODYNOPHAGIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
LYMPHOCYTOSIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
FATIGUE
|
6.0%
4/67 • Number of events 7 • Up to 24 months after enrollment
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
TRISMUS
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
DRY SKIN
|
4.5%
3/67 • Number of events 4 • Up to 24 months after enrollment
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
PAIN IN EXTREMITY
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
HYPERTHERMIA
|
7.5%
5/67 • Number of events 5 • Up to 24 months after enrollment
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
CHEST PAIN
|
6.0%
4/67 • Number of events 4 • Up to 24 months after enrollment
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
CATHETER SITE PAIN
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
DUMPING SYNDROME
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
NERVOUS SYSTEM DISORDERS
TREMOR
|
4.5%
3/67 • Number of events 3 • Up to 24 months after enrollment
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
CHILLS
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
PSYCHIATRIC DISORDERS
SLEEP DISORDER
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
INFUSION SITE REACTION
|
1.5%
1/67 • Number of events 2 • Up to 24 months after enrollment
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
BACK PAIN
|
6.0%
4/67 • Number of events 5 • Up to 24 months after enrollment
|
|
VASCULAR DISORDERS
HYPERTENSION
|
4.5%
3/67 • Number of events 3 • Up to 24 months after enrollment
|
|
NERVOUS SYSTEM DISORDERS
DIZZINESS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
SEPSIS
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
FUNGAL INFECTION
|
4.5%
3/67 • Number of events 3 • Up to 24 months after enrollment
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
INFUSION RELATED REACTION
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
XEROSIS
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
PARAESTHESIA ORAL
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INVESTIGATIONS
N-TERMINAL PROHORMONE BRAIN NATRIURETIC PEPTIDE INCREASED
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL PAIN UPPER
|
7.5%
5/67 • Number of events 5 • Up to 24 months after enrollment
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
RASH
|
10.4%
7/67 • Number of events 7 • Up to 24 months after enrollment
|
|
METABOLISM AND NUTRITION DISORDERS
HYPOKALAEMIA
|
14.9%
10/67 • Number of events 12 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
URINARY TRACT INFECTION
|
6.0%
4/67 • Number of events 4 • Up to 24 months after enrollment
|
|
SURGICAL AND MEDICAL PROCEDURES
GASTROINTESTINAL TUBE REMOVAL
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
METABOLISM AND NUTRITION DISORDERS
DEHYDRATION
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
SUBCUTANEOUS ABSCESS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
RHINITIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
ECZEMA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
METABOLISM AND NUTRITION DISORDERS
DECREASED APPETITE
|
44.8%
30/67 • Number of events 45 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
NAUSEA
|
82.1%
55/67 • Number of events 95 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
DIARRHOEA
|
86.6%
58/67 • Number of events 102 • Up to 24 months after enrollment
|
|
NERVOUS SYSTEM DISORDERS
NEUROPATHY PERIPHERAL
|
47.8%
32/67 • Number of events 49 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
VOMITING
|
38.8%
26/67 • Number of events 38 • Up to 24 months after enrollment
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
ASTHENIA
|
89.6%
60/67 • Number of events 113 • Up to 24 months after enrollment
|
|
NERVOUS SYSTEM DISORDERS
DYSGEUSIA
|
16.4%
11/67 • Number of events 13 • Up to 24 months after enrollment
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PYREXIA
|
19.4%
13/67 • Number of events 19 • Up to 24 months after enrollment
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
NEUTROPENIA
|
31.3%
21/67 • Number of events 26 • Up to 24 months after enrollment
|
|
INFECTIONS AND INFESTATIONS
BRONCHITIS
|
4.5%
3/67 • Number of events 3 • Up to 24 months after enrollment
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
ALOPECIA
|
34.3%
23/67 • Number of events 23 • Up to 24 months after enrollment
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
OEDEMA PERIPHERAL
|
7.5%
5/67 • Number of events 5 • Up to 24 months after enrollment
|
|
NERVOUS SYSTEM DISORDERS
PARAESTHESIA
|
23.9%
16/67 • Number of events 26 • Up to 24 months after enrollment
|
|
VASCULAR DISORDERS
HOT FLUSH
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
17.9%
12/67 • Number of events 13 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL PAIN
|
26.9%
18/67 • Number of events 23 • Up to 24 months after enrollment
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
ANAEMIA
|
22.4%
15/67 • Number of events 16 • Up to 24 months after enrollment
|
|
INVESTIGATIONS
WEIGHT DECREASED
|
34.3%
23/67 • Number of events 25 • Up to 24 months after enrollment
|
|
PSYCHIATRIC DISORDERS
ANXIETY
|
4.5%
3/67 • Number of events 3 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
CONSTIPATION
|
14.9%
10/67 • Number of events 11 • Up to 24 months after enrollment
|
|
HEPATOBILIARY DISORDERS
HEPATIC CYTOLYSIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
ARTHRALGIA
|
6.0%
4/67 • Number of events 4 • Up to 24 months after enrollment
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MYALGIA
|
6.0%
4/67 • Number of events 4 • Up to 24 months after enrollment
|
|
NERVOUS SYSTEM DISORDERS
HYPOAESTHESIA
|
4.5%
3/67 • Number of events 3 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
PANCREATIC FISTULA
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
ILEUS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
INGUINAL HERNIA
|
3.0%
2/67 • Number of events 2 • Up to 24 months after enrollment
|
|
GASTROINTESTINAL DISORDERS
ANORECTAL DISCOMFORT
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
NERVOUS SYSTEM DISORDERS
HEADACHE
|
4.5%
3/67 • Number of events 3 • Up to 24 months after enrollment
|
|
HEPATOBILIARY DISORDERS
HEPATIC STEATOSIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
PSYCHIATRIC DISORDERS
DEPRESSIVE SYMPTOM
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
EYE DISORDERS
EYE PAIN
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PNEUMOTHORAX
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PLEURAL EFFUSION
|
6.0%
4/67 • Number of events 4 • Up to 24 months after enrollment
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
HYPERLEUKOCYTOSIS
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
INFLAMMATION
|
4.5%
3/67 • Number of events 3 • Up to 24 months after enrollment
|
|
NERVOUS SYSTEM DISORDERS
NEUROTOXICITY
|
17.9%
12/67 • Number of events 17 • Up to 24 months after enrollment
|
|
METABOLISM AND NUTRITION DISORDERS
HYPOALBUMINAEMIA
|
1.5%
1/67 • Number of events 1 • Up to 24 months after enrollment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place