Trial Outcomes & Findings for Prognostic Impact of the Neutrophil/Lymphocyte Ratio (NLR) in the Treatment of First-line Metastatic or Locally Advanced Breast Cancer Treated With CDK4/6 Inhibitor. (NCT NCT05303129)
NCT ID: NCT05303129
Last Updated: 2026-06-11
Results Overview
Progression-free survival rate according to the Neutrophil/Lymphocyte (NLR) ratio. NLR cut-off set at 2.53
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
165 participants
Primary outcome timeframe
At 12 months after initiation of CDK 4/6 treatment
Results posted on
2026-06-11
Participant Flow
Participant milestones
| Measure |
Blood Tests
Realization of 4 blood tests for Lymphocyte typing (Neutrophil/Lymphocyte ratio (NLR), CD4+ and CD8+ lymphocyte counts ), during CDK4/6 treatment :
* before initiation of CDK4/6 treatment
* At 3 mois after initiation of CDK4/6 treatment
* At 6 mois after initiation of CDK4/6 treatment
* At 12 mois after initiation of CDK4/6 treatment or at early end of study
|
|---|---|
|
Overall Study
STARTED
|
165
|
|
Overall Study
COMPLETED
|
163
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Blood Tests
Realization of 4 blood tests for Lymphocyte typing (Neutrophil/Lymphocyte ratio (NLR), CD4+ and CD8+ lymphocyte counts ), during CDK4/6 treatment :
* before initiation of CDK4/6 treatment
* At 3 mois after initiation of CDK4/6 treatment
* At 6 mois after initiation of CDK4/6 treatment
* At 12 mois after initiation of CDK4/6 treatment or at early end of study
|
|---|---|
|
Overall Study
Protocol Violation
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Blood Tests
n=163 Participants
Realization of 4 blood tests for Lymphocyte typing (Neutrophil/Lymphocyte ratio (NLR), CD4+ and CD8+ lymphocyte counts ), during CDK4/6 treatment :
* before initiation of CDK4/6 treatment
* At 3 mois after initiation of CDK4/6 treatment
* At 6 mois after initiation of CDK4/6 treatment
* At 12 mois after initiation of CDK4/6 treatment or at early end of study
|
|---|---|
|
Age, Continuous
|
66 years
n=163 Participants
|
|
Sex: Female, Male
Female
|
163 Participants
n=163 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=163 Participants
|
|
CDK 4/6 treatment type
Palbociclib
|
23 Participants
n=163 Participants
|
|
CDK 4/6 treatment type
Ribociclib
|
87 Participants
n=163 Participants
|
|
CDK 4/6 treatment type
Abemaciclib
|
53 Participants
n=163 Participants
|
PRIMARY outcome
Timeframe: At 12 months after initiation of CDK 4/6 treatmentProgression-free survival rate according to the Neutrophil/Lymphocyte (NLR) ratio. NLR cut-off set at 2.53
Outcome measures
| Measure |
NLR Under 2.53
n=67 Participants
Patients with pre-treatment neutrophil lymphocyte rate lower or equal than 2.53
|
NLR Over 2.53
n=96 Participants
Patients with pre-treamtent neutrophil to lymphocyte rate higher than 2.53
|
|---|---|---|
|
Progression-free Survival Rate
|
57 Participants
|
70 Participants
|
Adverse Events
Blood Tests
Serious events: 0 serious events
Other events: 159 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Blood Tests
n=165 participants at risk
Realization of 4 blood tests for Lymphocyte typing (Neutrophil/Lymphocyte ratio (NLR), CD4+ and CD8+ lymphocyte counts ), during CDK4/6 treatment :
* before initiation of CDK4/6 treatment
* At 3 mois after initiation of CDK4/6 treatment
* At 6 mois after initiation of CDK4/6 treatment
* At 12 mois after initiation of CDK4/6 treatment or at early end of study
|
|---|---|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
ASTHENIA
|
49.7%
82/165 • Number of events 86 • Up to 12 months after inclusion
|
|
GASTROINTESTINAL DISORDERS
DIARRHOEA
|
36.4%
60/165 • Number of events 66 • Up to 12 months after inclusion
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
THROMBOCYTOPENIA
|
4.8%
8/165 • Number of events 9 • Up to 12 months after inclusion
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
NEUTROPENIA
|
55.2%
91/165 • Number of events 155 • Up to 12 months after inclusion
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
ANAEMIA
|
6.7%
11/165 • Number of events 15 • Up to 12 months after inclusion
|
|
INFECTIONS AND INFESTATIONS
ERYSIPELAS
|
1.8%
3/165 • Number of events 3 • Up to 12 months after inclusion
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
LYMPHOPENIA
|
1.2%
2/165 • Number of events 2 • Up to 12 months after inclusion
|
|
INFECTIONS AND INFESTATIONS
COVID-19
|
4.2%
7/165 • Number of events 8 • Up to 12 months after inclusion
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
RASH
|
4.8%
8/165 • Number of events 9 • Up to 12 months after inclusion
|
|
METABOLISM AND NUTRITION DISORDERS
DECREASED APPETITE
|
10.3%
17/165 • Number of events 17 • Up to 12 months after inclusion
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL PAIN
|
6.7%
11/165 • Number of events 11 • Up to 12 months after inclusion
|
|
METABOLISM AND NUTRITION DISORDERS
CELL DEATH
|
2.4%
4/165 • Number of events 4 • Up to 12 months after inclusion
|
|
NERVOUS SYSTEM DISORDERS
DIZZINESS
|
1.2%
2/165 • Number of events 3 • Up to 12 months after inclusion
|
|
RENAL AND URINARY DISORDERS
POLLAKIURIA
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
GASTROINTESTINAL DISORDERS
NAUSEA
|
25.5%
42/165 • Number of events 42 • Up to 12 months after inclusion
|
|
VASCULAR DISORDERS
HOT FLUSH
|
15.8%
26/165 • Number of events 26 • Up to 12 months after inclusion
|
|
GASTROINTESTINAL DISORDERS
SUBILEUS
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
ALOPECIA
|
9.1%
15/165 • Number of events 15 • Up to 12 months after inclusion
|
|
SURGICAL AND MEDICAL PROCEDURES
TOOTH EXTRACTION
|
1.8%
3/165 • Number of events 3 • Up to 12 months after inclusion
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MUCOSAL INFLAMMATION
|
3.6%
6/165 • Number of events 6 • Up to 12 months after inclusion
|
|
HEPATOBILIARY DISORDERS
HEPATIC CYTOLYSIS
|
7.3%
12/165 • Number of events 17 • Up to 12 months after inclusion
|
|
HEPATOBILIARY DISORDERS
CHOLESTASIS
|
3.0%
5/165 • Number of events 5 • Up to 12 months after inclusion
|
|
INVESTIGATIONS
TRANSAMINASES INCREASED
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
METABOLISM AND NUTRITION DISORDERS
DEHYDRATION
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
METABOLISM AND NUTRITION DISORDERS
HYPOKALAEMIA
|
1.2%
2/165 • Number of events 2 • Up to 12 months after inclusion
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
BACK PAIN
|
2.4%
4/165 • Number of events 4 • Up to 12 months after inclusion
|
|
GASTROINTESTINAL DISORDERS
CONSTIPATION
|
9.7%
16/165 • Number of events 16 • Up to 12 months after inclusion
|
|
INFECTIONS AND INFESTATIONS
ORAL HERPES
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MUSCULOSKELETAL PAIN
|
2.4%
4/165 • Number of events 4 • Up to 12 months after inclusion
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
ERYTHEMA
|
1.2%
2/165 • Number of events 2 • Up to 12 months after inclusion
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MYALGIA
|
1.8%
3/165 • Number of events 3 • Up to 12 months after inclusion
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
ARTHRALGIA
|
10.3%
17/165 • Number of events 17 • Up to 12 months after inclusion
|
|
INVESTIGATIONS
BLOOD CREATININE INCREASED
|
2.4%
4/165 • Number of events 4 • Up to 12 months after inclusion
|
|
NERVOUS SYSTEM DISORDERS
TRANSIENT ISCHAEMIC ATTACK
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
NERVOUS SYSTEM DISORDERS
MIGRAINE
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
PSYCHIATRIC DISORDERS
INSOMNIA
|
3.0%
5/165 • Number of events 5 • Up to 12 months after inclusion
|
|
PSYCHIATRIC DISORDERS
ANXIETY
|
1.2%
2/165 • Number of events 2 • Up to 12 months after inclusion
|
|
NERVOUS SYSTEM DISORDERS
DYSGEUSIA
|
1.8%
3/165 • Number of events 3 • Up to 12 months after inclusion
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
COUGH
|
0.61%
1/165 • Number of events 2 • Up to 12 months after inclusion
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
DYSPNOEA
|
2.4%
4/165 • Number of events 4 • Up to 12 months after inclusion
|
|
INFECTIONS AND INFESTATIONS
PNEUMONIA
|
1.8%
3/165 • Number of events 3 • Up to 12 months after inclusion
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
GENERAL PHYSICAL HEALTH DETERIORATION
|
3.0%
5/165 • Number of events 5 • Up to 12 months after inclusion
|
|
GASTROINTESTINAL DISORDERS
VOMITING
|
3.6%
6/165 • Number of events 6 • Up to 12 months after inclusion
|
|
INFECTIONS AND INFESTATIONS
SEPSIS
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
VASCULAR DISORDERS
VENOUS THROMBOSIS
|
1.2%
2/165 • Number of events 2 • Up to 12 months after inclusion
|
|
INFECTIONS AND INFESTATIONS
DEVICE RELATED INFECTION
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
RENAL AND URINARY DISORDERS
RENAL FAILURE
|
1.8%
3/165 • Number of events 3 • Up to 12 months after inclusion
|
|
NERVOUS SYSTEM DISORDERS
HEADACHE
|
3.0%
5/165 • Number of events 5 • Up to 12 months after inclusion
|
|
INFECTIONS AND INFESTATIONS
BRONCHITIS
|
1.8%
3/165 • Number of events 3 • Up to 12 months after inclusion
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
DRY SKIN
|
5.5%
9/165 • Number of events 9 • Up to 12 months after inclusion
|
|
INFECTIONS AND INFESTATIONS
RESPIRATORY SYNCYTIAL VIRUS INFECTION
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PULMONARY EMBOLISM
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
LUNG DISORDER
|
1.8%
3/165 • Number of events 3 • Up to 12 months after inclusion
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
UTERINE PROLAPSE
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
NERVOUS SYSTEM DISORDERS
MEMORY IMPAIRMENT
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
GASTROINTESTINAL DISORDERS
DYSPHAGIA
|
1.8%
3/165 • Number of events 3 • Up to 12 months after inclusion
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MUSCLE SPASMS
|
1.2%
2/165 • Number of events 2 • Up to 12 months after inclusion
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PYREXIA
|
2.4%
4/165 • Number of events 4 • Up to 12 months after inclusion
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
URTICARIA
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
PRURITUS
|
4.8%
8/165 • Number of events 8 • Up to 12 months after inclusion
|
|
INFECTIONS AND INFESTATIONS
URINARY TRACT INFECTION
|
1.8%
3/165 • Number of events 3 • Up to 12 months after inclusion
|
|
NERVOUS SYSTEM DISORDERS
NEUROPATHY PERIPHERAL
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
INVESTIGATIONS
WEIGHT INCREASED
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
INFECTIONS AND INFESTATIONS
MALARIA
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
OEDEMA PERIPHERAL
|
1.2%
2/165 • Number of events 2 • Up to 12 months after inclusion
|
|
GASTROINTESTINAL DISORDERS
COLITIS ISCHAEMIC
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
GASTROINTESTINAL DISORDERS
GASTROOESOPHAGEAL REFLUX DISEASE
|
1.8%
3/165 • Number of events 3 • Up to 12 months after inclusion
|
|
SURGICAL AND MEDICAL PROCEDURES
MASTECTOMY
|
1.2%
2/165 • Number of events 2 • Up to 12 months after inclusion
|
|
GASTROINTESTINAL DISORDERS
DYSPEPSIA
|
1.2%
2/165 • Number of events 2 • Up to 12 months after inclusion
|
|
RENAL AND URINARY DISORDERS
ACUTE KIDNEY INJURY
|
1.2%
2/165 • Number of events 2 • Up to 12 months after inclusion
|
|
INVESTIGATIONS
WEIGHT DECREASED
|
1.8%
3/165 • Number of events 3 • Up to 12 months after inclusion
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
BREAST PAIN
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
INVESTIGATIONS
ELECTROCARDIOGRAM QT PROLONGED
|
1.8%
3/165 • Number of events 3 • Up to 12 months after inclusion
|
|
RENAL AND URINARY DISORDERS
NEPHROPATHY TOXIC
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
HEPATOBILIARY DISORDERS
HEPATIC FUNCTION ABNORMAL
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
CHEST PAIN
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
INFECTIONS AND INFESTATIONS
BREAST ABSCESS
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
FATIGUE
|
3.0%
5/165 • Number of events 6 • Up to 12 months after inclusion
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
BONE PAIN
|
1.2%
2/165 • Number of events 2 • Up to 12 months after inclusion
|
|
PSYCHIATRIC DISORDERS
DEPRESSION
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
INFECTIONS AND INFESTATIONS
SPINAL CORD INFECTION
|
1.2%
2/165 • Number of events 2 • Up to 12 months after inclusion
|
|
GASTROINTESTINAL DISORDERS
OESOPHAGITIS
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
ACUTE INTERSTITIAL PNEUMONITIS
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
ONYCHOLYSIS
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
NERVOUS SYSTEM DISORDERS
EPILEPSY
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
GASTROINTESTINAL DISORDERS
GASTROINTESTINAL MOTILITY DISORDER
|
1.2%
2/165 • Number of events 2 • Up to 12 months after inclusion
|
|
NERVOUS SYSTEM DISORDERS
SCIATICA
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
HUMERUS FRACTURE
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
PANNICULITIS
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
INFECTIONS AND INFESTATIONS
TOOTH INFECTION
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
PANCYTOPENIA
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
INTERSTITIAL LUNG DISEASE
|
1.8%
3/165 • Number of events 3 • Up to 12 months after inclusion
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
DYSPNOEA EXERTIONAL
|
1.2%
2/165 • Number of events 2 • Up to 12 months after inclusion
|
|
VASCULAR DISORDERS
HYPOTENSION
|
1.2%
2/165 • Number of events 2 • Up to 12 months after inclusion
|
|
GASTROINTESTINAL DISORDERS
TOOTHACHE
|
0.61%
1/165 • Number of events 2 • Up to 12 months after inclusion
|
|
PSYCHIATRIC DISORDERS
AFFECTIVE DISORDER
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
PSYCHIATRIC DISORDERS
SUICIDE ATTEMPT
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
SURGICAL AND MEDICAL PROCEDURES
HOSPITALISATION
|
0.61%
1/165 • Number of events 2 • Up to 12 months after inclusion
|
|
SURGICAL AND MEDICAL PROCEDURES
PSYCHIATRIC CARE
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
HYPERCREATINAEMIA
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
FASCIITIS
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
GASTROINTESTINAL DISORDERS
APHTHOUS ULCER
|
2.4%
4/165 • Number of events 4 • Up to 12 months after inclusion
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
NAIL DISORDER
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
SURGICAL AND MEDICAL PROCEDURES
DENTAL CARE
|
0.61%
1/165 • Number of events 2 • Up to 12 months after inclusion
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MUSCULOSKELETAL STIFFNESS
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
AMENORRHOEA
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
VAGINAL DISCHARGE
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
PSYCHIATRIC DISORDERS
SLEEP DISORDER
|
1.2%
2/165 • Number of events 2 • Up to 12 months after inclusion
|
|
GASTROINTESTINAL DISORDERS
DRY MOUTH
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MUSCULOSKELETAL CHEST PAIN
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
1.2%
2/165 • Number of events 2 • Up to 12 months after inclusion
|
|
NERVOUS SYSTEM DISORDERS
MOTOR DYSFUNCTION
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
NERVOUS SYSTEM DISORDERS
SENSORY LOSS
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
INVESTIGATIONS
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
INVESTIGATIONS
ALANINE AMINOTRANSFERASE INCREASED
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PAIN
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
HEPATOBILIARY DISORDERS
LIVER DISORDER
|
1.2%
2/165 • Number of events 2 • Up to 12 months after inclusion
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
RADIATION OESOPHAGITIS
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
VASCULAR DISORDERS
HAEMORRHAGE
|
1.2%
2/165 • Number of events 2 • Up to 12 months after inclusion
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
ERYTHEMA ANNULARE
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
INFECTIONS AND INFESTATIONS
VULVOVAGINAL MYCOTIC INFECTION
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL PAIN UPPER
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
ECZEMA
|
1.2%
2/165 • Number of events 3 • Up to 12 months after inclusion
|
|
EYE DISORDERS
DRY EYE
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
METABOLISM AND NUTRITION DISORDERS
HYPERKALAEMIA
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
INFECTIONS AND INFESTATIONS
CHEST WALL ABSCESS
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
DIFFUSE ALOPECIA
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
ROSACEA
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
OSTEONECROSIS
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
NERVOUS SYSTEM DISORDERS
AMNESTIC DISORDER
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
RASH MACULO-PAPULAR
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
NERVOUS SYSTEM DISORDERS
TASTE DISORDER
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
INFLUENZA LIKE ILLNESS
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
NERVOUS SYSTEM DISORDERS
NEURALGIA
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
INFECTIONS AND INFESTATIONS
CYSTITIS
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
VULVOVAGINAL DRYNESS
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
JOINT STIFFNESS
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
|
EYE DISORDERS
LACRIMATION INCREASED
|
0.61%
1/165 • Number of events 1 • Up to 12 months after inclusion
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place