Trial Outcomes & Findings for Cabozantinib for Advanced or Metastatic Cervical Carcinoma After Platinum Treatment Failure (NCT NCT04205799)
NCT ID: NCT04205799
Last Updated: 2026-07-31
Results Overview
Efficacy assessed by the proportion of patients with disease control rate. Disease Control Rate (DCR) was defined as the proportion of participants who achieved complete response (CR), partial response (PR), or stable disease (SD) as their best overall response, according to the study-specific tumor response assessment criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
3 months after cabozantinib treatment initiation.
Results posted on
2026-07-31
Participant Flow
74 were entered in database, 17 were screen failure. 3 patients were not assessable because not treated.
Participant milestones
| Measure |
CABOZANTINIB
Cabozantinib will be administered at the daily dose of 60 mg given orally in a 4-week cycle. It will be continued without interruption until disease progression or discontinuation for any cause.
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
CABOZANTINIB
Cabozantinib will be administered at the daily dose of 60 mg given orally in a 4-week cycle. It will be continued without interruption until disease progression or discontinuation for any cause.
|
|---|---|
|
Overall Study
Protocol Violation
|
3
|
Baseline Characteristics
3 patients were not assessable because not treated by cabozantinib
Baseline characteristics by cohort
| Measure |
CABOZANTINIB
n=54 Participants
Cabozantinib will be administered at the daily dose of 60 mg given orally in a 4-week cycle. It will be continued without interruption until disease progression or discontinuation for any cause.
|
|---|---|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 11.1 • n=54 Participants • 3 patients were not assessable because not treated by cabozantinib
|
|
Sex: Female, Male
Female
|
54 Participants
n=54 Participants • 3 patients were not assessable because not treated by cabozantinib
|
|
Sex: Female, Male
Male
|
0 Participants
n=54 Participants • 3 patients were not assessable because not treated by cabozantinib
|
|
Bevacizumab pre-treatment
|
28 Participants
n=54 Participants
|
PRIMARY outcome
Timeframe: 3 months after cabozantinib treatment initiation.Population: 3 patients were not assessable because not treated by cabozantinib
Efficacy assessed by the proportion of patients with disease control rate. Disease Control Rate (DCR) was defined as the proportion of participants who achieved complete response (CR), partial response (PR), or stable disease (SD) as their best overall response, according to the study-specific tumor response assessment criteria.
Outcome measures
| Measure |
CABOZANTINIB
n=54 Participants
Cabozantinib will be administered at the daily dose of 60 mg given orally in a 4-week cycle. It will be continued without interruption until disease progression or discontinuation for any cause.
|
|---|---|
|
Efficacy of Cabozantinib: Proportion of Patients With Disease Control Rate
|
25 Participants
|
PRIMARY outcome
Timeframe: toxicities occurring up to 1 month after the end of treatmentSafety assessed by the proportion of patients with clinical gastro-intestinal (GI) perforation/fistula, GI-vaginal fistula and genito-urinary (GU) fistula events grade ≥ 2 (NCI CTCAE v 5.0)
Outcome measures
| Measure |
CABOZANTINIB
n=54 Participants
Cabozantinib will be administered at the daily dose of 60 mg given orally in a 4-week cycle. It will be continued without interruption until disease progression or discontinuation for any cause.
|
|---|---|
|
Safety of Cabozantinib: Proportion of Patients With Clinical Gastro-intestinal (GI) Perforation/Fistula, GI-vaginal Fistula and Genito-urinary (GU) Fistula Events Grade ≥ 2 (NCI CTCAE v 5.0)
|
5 Participants
|
SECONDARY outcome
Timeframe: From treatment start up to 24 monthsPopulation: 3 patients were not assessable because not treated by cabozantinib
Objective response rate defined as the percentage of patients who have achieved complete response or partial response with RECIST 1.1 criteria.
Outcome measures
| Measure |
CABOZANTINIB
n=54 Participants
Cabozantinib will be administered at the daily dose of 60 mg given orally in a 4-week cycle. It will be continued without interruption until disease progression or discontinuation for any cause.
|
|---|---|
|
Objective Response (RECIST v1.1 Criteria)
|
5 Participants
|
SECONDARY outcome
Timeframe: At the end of cycle 3,6,9... (each cycle is 28 days) through study completion, an average of 1 follow-up yearPopulation: 3 patients were not assessable because not treated by cabozantinib
Progression-free survival, defined as the time between initiation of cabozantinib treatment and progression (RECIST 1.1 criteria) or death of any cause whichever occurs first.
Outcome measures
| Measure |
CABOZANTINIB
n=54 Participants
Cabozantinib will be administered at the daily dose of 60 mg given orally in a 4-week cycle. It will be continued without interruption until disease progression or discontinuation for any cause.
|
|---|---|
|
Progression-free Survival (PFS)
|
2.81 months
Interval 2.53 to 4.57
|
SECONDARY outcome
Timeframe: through study completion, an average of 1 follow-up yearPopulation: 3 patients not assessable because not treated by cabozantinib
Overall survival, defined as the time between initiation of cabozantinib treatment and death of whatever cause.
Outcome measures
| Measure |
CABOZANTINIB
n=54 Participants
Cabozantinib will be administered at the daily dose of 60 mg given orally in a 4-week cycle. It will be continued without interruption until disease progression or discontinuation for any cause.
|
|---|---|
|
Overall Survival
|
8.94 month
Interval 6.67 to 12.5
|
SECONDARY outcome
Timeframe: every cycle of treatment (each cycle is 28 days) through study completion, an average of 1 follow-up yearPopulation: 3 patients were not assessable because not treated by cabozantinib
Rate of patients observing at least one toxicity, evaluated according to NCI CTCAE v5.0 criteria. Details will then be given in Adverse Events section.
Outcome measures
| Measure |
CABOZANTINIB
n=54 Participants
Cabozantinib will be administered at the daily dose of 60 mg given orally in a 4-week cycle. It will be continued without interruption until disease progression or discontinuation for any cause.
|
|---|---|
|
Safety Profile of Cabozantinib
|
54 Participants
|
SECONDARY outcome
Timeframe: At Day 15 of cycle 2 (each cycle is 28 days)Population: 40 of 54 patients filled questionnaire at Day 15 cycle 2.
The EORTC QLQ-C30 is a validated questionnaire used to assess health-related quality of life in cancer patients. It measures global quality of life, functional status, and symptom burden. The EORTC QLQ-CX24 is a cervical cancer-specific module that complements the QLQ-C30 by evaluating disease- and treatment-related symptoms, body image, and sexual functioning. For both questionnaires, raw scores are linearly transformed to a standardized scale ranging from 0 to 100. Higher scores on functional and global quality-of-life scales indicate better functioning and quality of life, whereas higher scores on symptom scales indicate greater symptom severity or more problems. For the QLQ-CX24, higher scores on sexual activity and sexual enjoyment reflect better functioning. In general, high functional scores and low symptom scores indicate a more favorable health-related quality of life.
Outcome measures
| Measure |
CABOZANTINIB
n=40 Participants
Cabozantinib will be administered at the daily dose of 60 mg given orally in a 4-week cycle. It will be continued without interruption until disease progression or discontinuation for any cause.
|
|---|---|
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Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
Functional scale - Physical functioning
|
66.3 units on a scale
Standard Deviation 25.5
|
|
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
Functional scale - Role functioning
|
59.8 units on a scale
Standard Deviation 34.8
|
|
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
Functional scale - Emotional functioning
|
77.3 units on a scale
Standard Deviation 23.5
|
|
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
Functional scale - Cognitive functioning
|
83.3 units on a scale
Standard Deviation 18.1
|
|
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
Functional scale - Social functioning
|
68.5 units on a scale
Standard Deviation 27.4
|
|
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
Globlal health status / quality-of-life
|
55.2 units on a scale
Standard Deviation 19.2
|
|
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
Symptom scale - Fatigue
|
55.8 units on a scale
Standard Deviation 30.1
|
|
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
Symptom scale - Nausea vomiting
|
20.1 units on a scale
Standard Deviation 28.1
|
|
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
Symptom scale - Pain
|
38.8 units on a scale
Standard Deviation 32.5
|
|
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
Symptom scale - Dyspnoea
|
23.3 units on a scale
Standard Deviation 28.5
|
|
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
Symptom scale - Sleep disorder
|
27.5 units on a scale
Standard Deviation 34.5
|
|
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
Symptom scale - Appetite loss
|
37.5 units on a scale
Standard Deviation 37.1
|
|
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
Symptom scale - Constipation
|
24.2 units on a scale
Standard Deviation 37
|
|
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
Symptom scale - Diarrhoea
|
49.2 units on a scale
Standard Deviation 37.7
|
|
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
Symptom scale - Financial difficulties
|
15.8 units on a scale
Standard Deviation 28.2
|
|
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
Symptom scale - Symptom experience
|
10.8 units on a scale
Standard Deviation 10.8
|
|
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
Functional assessments - Body image
|
41.0 units on a scale
Standard Deviation 41.5
|
|
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
Functional assessments - Sexual vaginal functionning
|
27.8 units on a scale
Standard Deviation 34.9
|
|
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
Symptom scale - Lymphodema
|
13.7 units on a scale
Standard Deviation 26.2
|
|
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
Symptom scale - Peripheral neuropathy
|
35.8 units on a scale
Standard Deviation 36.5
|
|
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
Symptom scale - Menopausal symptoms
|
16.7 units on a scale
Standard Deviation 28.2
|
|
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
Functional assessments - Sexual enjoyment
|
35.2 units on a scale
Standard Deviation 42.7
|
Adverse Events
CABOZANTINIB
Serious events: 26 serious events
Other events: 54 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
CABOZANTINIB
n=54 participants at risk
Cabozantinib will be administered at the daily dose of 60 mg given orally in a 4-week cycle. It will be continued without interruption until disease progression or discontinuation for any cause.
|
|---|---|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
GROIN PAIN
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
GASTROINTESTINAL PERFORATION
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
GENERAL PHYSICAL HEALTH DETERIORATION
|
5.6%
3/54 • Number of events 3 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
COLONIC FISTULA
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
SPINAL COMPRESSION FRACTURE
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
SURGICAL AND MEDICAL PROCEDURES
VERTEBROPLASTY
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
SURGICAL AND MEDICAL PROCEDURES
ABSCESS DRAINAGE
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
INFECTIONS AND INFESTATIONS
PERIRECTAL ABSCESS
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
LYMPH NODE RUPTURE
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
FISTULA
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
THROMBOTIC MICROANGIOPATHY
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
RENAL AND URINARY DISORDERS
ACUTE KIDNEY INJURY
|
1.9%
1/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
INFECTIONS AND INFESTATIONS
COVID-19
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
METABOLISM AND NUTRITION DISORDERS
STARVATION
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
PELVIC PAIN
|
1.9%
1/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL PAIN
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
UTERINE FISTULA
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
RENAL AND URINARY DISORDERS
RENAL FAILURE
|
3.7%
2/54 • Number of events 3 • From treatment start until end of follow-up, up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
VAGINAL FISTULA
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
PRODUCT ISSUES
DEVICE OCCLUSION
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
INTESTINAL ISCHAEMIA
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
FATIGUE
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
VOMITING
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
NAUSEA
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PYREXIA
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
CHEST PAIN
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
DYSPNOEA
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
INFECTIONS AND INFESTATIONS
BRONCHOPULMONARY ASPERGILLOSIS
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
RENAL AND URINARY DISORDERS
UROGENITAL FISTULA
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
HODGKIN'S DISEASE
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
FEMALE GENITAL TRACT FISTULA
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
RENAL AND URINARY DISORDERS
RENAL VEIN THROMBOSIS
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PAIN
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
RECTAL HAEMORRHAGE
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MULTIPLE ORGAN DYSFUNCTION SYNDROME
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
INFECTIONS AND INFESTATIONS
SEPSIS
|
5.6%
3/54 • Number of events 3 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
GASTROINTESTINAL OBSTRUCTION
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PULMONARY EMBOLISM
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
Other adverse events
| Measure |
CABOZANTINIB
n=54 participants at risk
Cabozantinib will be administered at the daily dose of 60 mg given orally in a 4-week cycle. It will be continued without interruption until disease progression or discontinuation for any cause.
|
|---|---|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
OSTEOARTHRITIS
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
INFECTIONS AND INFESTATIONS
INFECTION
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
LYMPHOPENIA
|
5.6%
3/54 • Number of events 3 • From treatment start until end of follow-up, up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
HYPERHIDROSIS
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
REFLUX GASTRITIS
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
HYPOAESTHESIA
|
1.9%
1/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
EAR AND LABYRINTH DISORDERS
EAR DISCOMFORT
|
1.9%
1/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
RENAL AND URINARY DISORDERS
POLLAKIURIA
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
PROCTALGIA
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
SYNCOPE
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
MADAROSIS
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
RASH
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
THROAT IRRITATION
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
RENAL AND URINARY DISORDERS
RENAL FAILURE
|
5.6%
3/54 • Number of events 3 • From treatment start until end of follow-up, up to 24 months
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
NECK PAIN
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
EPISTAXIS
|
5.6%
3/54 • Number of events 3 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL DISTENSION
|
3.7%
2/54 • Number of events 3 • From treatment start until end of follow-up, up to 24 months
|
|
VASCULAR DISORDERS
SUBCLAVIAN VEIN OCCLUSION
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
COMPLICATION ASSOCIATED WITH DEVICE
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
VASCULAR DISORDERS
LYMPHOEDEMA
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
HYPERKERATOSIS
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
VAGINAL HAEMORRHAGE
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
SURGICAL AND MEDICAL PROCEDURES
COLOSTOMY
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MALAISE
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
EAR AND LABYRINTH DISORDERS
TINNITUS
|
9.3%
5/54 • Number of events 5 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
GINGIVAL BLEEDING
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
VULVOVAGINAL INFLAMMATION
|
1.9%
1/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
FLANK PAIN
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MUSCLE SPASMS
|
11.1%
6/54 • Number of events 6 • From treatment start until end of follow-up, up to 24 months
|
|
ENDOCRINE DISORDERS
THYROID DISORDER
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
DYSPHAGIA
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
VOCAL CORD PARESIS
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL TENDERNESS
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
OEDEMA PERIPHERAL
|
5.6%
3/54 • Number of events 4 • From treatment start until end of follow-up, up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
SCIATICA
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
METABOLISM AND NUTRITION DISORDERS
CACHEXIA
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
METABOLISM AND NUTRITION DISORDERS
DEHYDRATION
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
METABOLISM AND NUTRITION DISORDERS
HYPOKALAEMIA
|
7.4%
4/54 • Number of events 4 • From treatment start until end of follow-up, up to 24 months
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
DYSPNOEA EXERTIONAL
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
INFECTIONS AND INFESTATIONS
TOOTH ABSCESS
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PERIPHERAL SWELLING
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
MIGRAINE
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
DRY SKIN
|
7.4%
4/54 • Number of events 4 • From treatment start until end of follow-up, up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
ONYCHOLYSIS
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
PSYCHIATRIC DISORDERS
INSOMNIA
|
9.3%
5/54 • Number of events 5 • From treatment start until end of follow-up, up to 24 months
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MYALGIA
|
5.6%
3/54 • Number of events 3 • From treatment start until end of follow-up, up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
PELVIC PAIN
|
9.3%
5/54 • Number of events 6 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
RECTAL HAEMORRHAGE
|
5.6%
3/54 • Number of events 3 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
SALIVARY HYPERSECRETION
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
INVESTIGATIONS
BLOOD THYROID STIMULATING HORMONE DECREASED
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
VASCULAR DISORDERS
PREHYPERTENSION
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
CHILLS
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PYREXIA
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
GASTROOESOPHAGEAL REFLUX DISEASE
|
9.3%
5/54 • Number of events 5 • From treatment start until end of follow-up, up to 24 months
|
|
VASCULAR DISORDERS
HOT FLUSH
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
SPINAL PAIN
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
ACNE
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
DYSPEPSIA
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
RHINORRHOEA
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
EYE DISORDERS
SCINTILLATING SCOTOMA
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
PAIN IN EXTREMITY
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
HEPATOBILIARY DISORDERS
CHOLESTASIS
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
INVESTIGATIONS
BLOOD PHOSPHORUS DECREASED
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MUSCULOSKELETAL PAIN
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
ENDOCRINE DISORDERS
HYPERTHYROIDISM
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MUCOSAL DRYNESS
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
RENAL AND URINARY DISORDERS
PROTEINURIA
|
3.7%
2/54 • Number of events 3 • From treatment start until end of follow-up, up to 24 months
|
|
EYE DISORDERS
VISUAL ACUITY REDUCED
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
INFECTIONS AND INFESTATIONS
ORAL HERPES
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
INVESTIGATIONS
BLOOD LACTATE DEHYDROGENASE INCREASED
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
RENAL AND URINARY DISORDERS
ACUTE KIDNEY INJURY
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
INFECTIONS AND INFESTATIONS
GINGIVITIS
|
5.6%
3/54 • Number of events 3 • From treatment start until end of follow-up, up to 24 months
|
|
VASCULAR DISORDERS
DEEP VEIN THROMBOSIS
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
CARDIAC DISORDERS
ASCITES
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
METABOLISM AND NUTRITION DISORDERS
HYPERCALCAEMIA
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
VULVOVAGINAL DRYNESS
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
VULVOVAGINAL DISCOMFORT
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
NEUROPATHY PERIPHERAL
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
IMPAIRED HEALING
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
INFECTIONS AND INFESTATIONS
PARONYCHIA
|
1.9%
1/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
BALANCE DISORDER
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
HEADACHE
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
DISTURBANCE IN ATTENTION
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
EYE DISORDERS
VISION BLURRED
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
PSYCHIATRIC DISORDERS
MENTAL FATIGUE
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
FLATULENCE
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
DERMATITIS DIAPER
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
RENAL AND URINARY DISORDERS
URINARY TRACT PAIN
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
INFECTIONS AND INFESTATIONS
VIRAL RHINITIS
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
INVESTIGATIONS
ASPARTATE AMINOTRANSFERASE INCREASED
|
5.6%
3/54 • Number of events 3 • From treatment start until end of follow-up, up to 24 months
|
|
INVESTIGATIONS
ALANINE AMINOTRANSFERASE INCREASED
|
5.6%
3/54 • Number of events 3 • From treatment start until end of follow-up, up to 24 months
|
|
INVESTIGATIONS
TRANSAMINASES INCREASED
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
STOMATITIS
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
DIZZINESS
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
SOMNOLENCE
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
RENAL AND URINARY DISORDERS
HAEMATURIA
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
TASTE DISORDER
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
VASCULAR DISORDERS
PERIPHERAL VENOUS DISEASE
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
INVESTIGATIONS
BLOOD ALKALINE PHOSPHATASE INCREASED
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
INVESTIGATIONS
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PRODUCTIVE COUGH
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
HEPATOBILIARY DISORDERS
HYDROCHOLECYSTIS
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
SURGICAL AND MEDICAL PROCEDURES
CHOLECYSTECTOMY
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
ERYTHEMA
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
INFECTIONS AND INFESTATIONS
EAR INFECTION
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
CARDIAC DISORDERS
ANGINA PECTORIS
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
INFLAMMATION
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
GENERAL PHYSICAL HEALTH DETERIORATION
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
NEUROTOXICITY
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL DISCOMFORT
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
SUBILEUS
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ERUCTATION
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PLEURAL EFFUSION
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
CARDIAC DISORDERS
TACHYCARDIA
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
BLISTER
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
DIARRHOEA
|
70.4%
38/54 • Number of events 58 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
CONSTIPATION
|
42.6%
23/54 • Number of events 27 • From treatment start until end of follow-up, up to 24 months
|
|
VASCULAR DISORDERS
HYPERTENSION
|
20.4%
11/54 • Number of events 13 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
TOOTHACHE
|
5.6%
3/54 • Number of events 3 • From treatment start until end of follow-up, up to 24 months
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
DYSPHONIA
|
5.6%
3/54 • Number of events 4 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
VOMITING
|
42.6%
23/54 • Number of events 27 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
DRY MOUTH
|
7.4%
4/54 • Number of events 4 • From treatment start until end of follow-up, up to 24 months
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
BACK PAIN
|
11.1%
6/54 • Number of events 6 • From treatment start until end of follow-up, up to 24 months
|
|
HEPATOBILIARY DISORDERS
HEPATIC CYTOLYSIS
|
27.8%
15/54 • Number of events 15 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
NAUSEA
|
46.3%
25/54 • Number of events 28 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL PAIN UPPER
|
5.6%
3/54 • Number of events 3 • From treatment start until end of follow-up, up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
INTERMENSTRUAL BLEEDING
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
DYSGEUSIA
|
20.4%
11/54 • Number of events 12 • From treatment start until end of follow-up, up to 24 months
|
|
METABOLISM AND NUTRITION DISORDERS
HYPOMAGNESAEMIA
|
14.8%
8/54 • Number of events 8 • From treatment start until end of follow-up, up to 24 months
|
|
INVESTIGATIONS
BLOOD THYROID STIMULATING HORMONE INCREASED
|
5.6%
3/54 • Number of events 3 • From treatment start until end of follow-up, up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
ASTHENIA
|
63.0%
34/54 • Number of events 43 • From treatment start until end of follow-up, up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
FATIGUE
|
7.4%
4/54 • Number of events 4 • From treatment start until end of follow-up, up to 24 months
|
|
METABOLISM AND NUTRITION DISORDERS
DECREASED APPETITE
|
37.0%
20/54 • Number of events 23 • From treatment start until end of follow-up, up to 24 months
|
|
RENAL AND URINARY DISORDERS
URETHRAL PAIN
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
RENAL AND URINARY DISORDERS
DYSURIA
|
7.4%
4/54 • Number of events 4 • From treatment start until end of follow-up, up to 24 months
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
DYSPNOEA
|
18.5%
10/54 • Number of events 12 • From treatment start until end of follow-up, up to 24 months
|
|
INFECTIONS AND INFESTATIONS
NASOPHARYNGITIS
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
INFECTIONS AND INFESTATIONS
HERPES VIRUS INFECTION
|
1.9%
1/54 • Number of events 3 • From treatment start until end of follow-up, up to 24 months
|
|
SURGICAL AND MEDICAL PROCEDURES
TOOTH EXTRACTION
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
INFECTIONS AND INFESTATIONS
RHINITIS
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PAIN
|
11.1%
6/54 • Number of events 7 • From treatment start until end of follow-up, up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
31.5%
17/54 • Number of events 20 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
APHTHOUS ULCER
|
9.3%
5/54 • Number of events 6 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
NONINFECTIVE GINGIVITIS
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
ENDOCRINE DISORDERS
HYPOTHYROIDISM
|
13.0%
7/54 • Number of events 7 • From treatment start until end of follow-up, up to 24 months
|
|
INFECTIONS AND INFESTATIONS
URINARY TRACT INFECTION
|
5.6%
3/54 • Number of events 3 • From treatment start until end of follow-up, up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
ALOPECIA
|
11.1%
6/54 • Number of events 6 • From treatment start until end of follow-up, up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
NAIL DYSTROPHY
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
PSYCHIATRIC DISORDERS
ANXIETY
|
11.1%
6/54 • Number of events 6 • From treatment start until end of follow-up, up to 24 months
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
COUGH
|
13.0%
7/54 • Number of events 7 • From treatment start until end of follow-up, up to 24 months
|
|
PSYCHIATRIC DISORDERS
DEPRESSED MOOD
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
METABOLISM AND NUTRITION DISORDERS
HYPOALBUMINAEMIA
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
INVESTIGATIONS
WEIGHT DECREASED
|
16.7%
9/54 • Number of events 9 • From treatment start until end of follow-up, up to 24 months
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
ANAEMIA
|
13.0%
7/54 • Number of events 7 • From treatment start until end of follow-up, up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MUCOSAL INFLAMMATION
|
35.2%
19/54 • Number of events 23 • From treatment start until end of follow-up, up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
DERMATITIS ACNEIFORM
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
NEUTROPENIA
|
9.3%
5/54 • Number of events 7 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ANAL FISSURE
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
INFECTIONS AND INFESTATIONS
CYSTITIS
|
5.6%
3/54 • Number of events 3 • From treatment start until end of follow-up, up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
FEELING COLD
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL PAIN
|
22.2%
12/54 • Number of events 13 • From treatment start until end of follow-up, up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
VAGINAL DISCHARGE
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ANORECTAL DISCOMFORT
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
NEURALGIA
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
ARTHRALGIA
|
9.3%
5/54 • Number of events 5 • From treatment start until end of follow-up, up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
CHEST PAIN
|
11.1%
6/54 • Number of events 6 • From treatment start until end of follow-up, up to 24 months
|
|
INFECTIONS AND INFESTATIONS
ERYSIPELAS
|
1.9%
1/54 • Number of events 1 • From treatment start until end of follow-up, up to 24 months
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
THROMBOCYTOPENIA
|
16.7%
9/54 • Number of events 9 • From treatment start until end of follow-up, up to 24 months
|
|
VASCULAR DISORDERS
CAPILLARY DISORDER
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ANAL INFLAMMATION
|
3.7%
2/54 • Number of events 3 • From treatment start until end of follow-up, up to 24 months
|
|
GASTROINTESTINAL DISORDERS
HAEMORRHOIDS
|
3.7%
2/54 • Number of events 2 • From treatment start until end of follow-up, up to 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place