Trial Outcomes & Findings for Study of SIB-IMRT in Combination With 5-FU and Mitomycin-C Among Patients With Locally Advanced Anal Canal Cancer: Efficacy, Safety and Quality of Life (NCT NCT02701088)
NCT ID: NCT02701088
Last Updated: 2026-08-31
Results Overview
The 3-month locoregional control rate after the end of IMRT by helical tomotherapy defined by the proportion of patients alive with no local disease progression 3 months after the end of radiotherapy
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
3 months after the end of radiotherapy
Results posted on
2026-08-31
Participant Flow
Participant milestones
| Measure |
Concomitant Chemotherapy and Radiotherapy
Chemoradiotherapy with two cycles of 5FU and Mitomycin-C plus radiotherapy by SIB-IMRT (for simultaneous integrated boost intensity modulated radiation therapy) day 1 to day 50 in 36 fractions
|
|---|---|
|
Overall Study
STARTED
|
71
|
|
Overall Study
COMPLETED
|
70
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Concomitant Chemotherapy and Radiotherapy
Chemoradiotherapy with two cycles of 5FU and Mitomycin-C plus radiotherapy by SIB-IMRT (for simultaneous integrated boost intensity modulated radiation therapy) day 1 to day 50 in 36 fractions
|
|---|---|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Concomitant Chemotherapy and Radiotherapy
n=70 Participants
Chemoradiotherapy with two cycles of 5FU and Mitomycin-C plus radiotherapy by SIB-IMRT (for simultaneous integrated boost intensity modulated radiation therapy) day 1 to day 50 in 36 fractions
|
|---|---|
|
Age, Continuous
|
61.9 years
STANDARD_DEVIATION 9 • n=70 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=70 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=70 Participants
|
|
Histology
Well differentiated
|
16 Participants
n=70 Participants
|
|
Histology
Moderately differentiated transitional carcinoma
|
20 Participants
n=70 Participants
|
|
Histology
Poorly differentiated basaloid carcinoma
|
22 Participants
n=70 Participants
|
|
Histology
No further information available
|
12 Participants
n=70 Participants
|
PRIMARY outcome
Timeframe: 3 months after the end of radiotherapyThe 3-month locoregional control rate after the end of IMRT by helical tomotherapy defined by the proportion of patients alive with no local disease progression 3 months after the end of radiotherapy
Outcome measures
| Measure |
Concomitant Chemotherapy and Radiotherapy
n=70 Participants
Chemoradiotherapy with two cycles of 5FU and Mitomycin-C plus radiotherapy by SIB-IMRT (for simultaneous integrated boost intensity modulated radiation therapy) day 1 to day 50 in 36 fractions
|
|---|---|
|
Efficacy: The 3-month Locoregional Control Rate
|
63 Participants
|
PRIMARY outcome
Timeframe: Until 11 weeks after treatment startTolerance profile: Proportion of patients with no significant (grade ≥3 according to NCI CTCAE v4.03) toxicities responsible for irradiation breaks
Outcome measures
| Measure |
Concomitant Chemotherapy and Radiotherapy
n=70 Participants
Chemoradiotherapy with two cycles of 5FU and Mitomycin-C plus radiotherapy by SIB-IMRT (for simultaneous integrated boost intensity modulated radiation therapy) day 1 to day 50 in 36 fractions
|
|---|---|
|
Tolerance Profile: Proportion of Patients With no Significant Toxicities Responsible for Irradiation Breaks
|
60 Participants
|
SECONDARY outcome
Timeframe: 6 months after treatment startThe EORTC QLQ-C30 is a cancer-specific health-related quality of life questionnaire comprising 30 items. It assesses five functional domains (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, pain, and nausea/vomiting), a global health status/quality of life scale, and several single-item symptom measures. Scores are linearly transformed to a 0-100 scale; higher functional and global health scores indicate better functioning/quality of life, whereas higher symptom scores indicate greater symptom burden.
Outcome measures
| Measure |
Concomitant Chemotherapy and Radiotherapy
n=70 Participants
Chemoradiotherapy with two cycles of 5FU and Mitomycin-C plus radiotherapy by SIB-IMRT (for simultaneous integrated boost intensity modulated radiation therapy) day 1 to day 50 in 36 fractions
|
|---|---|
|
Quality of Life Measured by the EORTC QLQ-C30 (Version 3.0)
Functional scale - Physical functioning
|
82.6 units on a scale
Standard Deviation 21.8
|
|
Quality of Life Measured by the EORTC QLQ-C30 (Version 3.0)
Functional scale - Role functioning
|
78.6 units on a scale
Standard Deviation 29.5
|
|
Quality of Life Measured by the EORTC QLQ-C30 (Version 3.0)
Functional scale - Emotional functionning
|
78.4 units on a scale
Standard Deviation 22.4
|
|
Quality of Life Measured by the EORTC QLQ-C30 (Version 3.0)
Functional scale - Cognitive functioning
|
87.8 units on a scale
Standard Deviation 17.8
|
|
Quality of Life Measured by the EORTC QLQ-C30 (Version 3.0)
Functional scale - Social functioning
|
83 units on a scale
Standard Deviation 24.4
|
|
Quality of Life Measured by the EORTC QLQ-C30 (Version 3.0)
Symptom scale - Fatigue
|
27.9 units on a scale
Standard Deviation 25.1
|
|
Quality of Life Measured by the EORTC QLQ-C30 (Version 3.0)
Symptom scale - Nausea and vomiting
|
6.46 units on a scale
Standard Deviation 15.5
|
|
Quality of Life Measured by the EORTC QLQ-C30 (Version 3.0)
Symptom scale - Pain
|
20.1 units on a scale
Standard Deviation 27.6
|
|
Quality of Life Measured by the EORTC QLQ-C30 (Version 3.0)
Symptom scale - Dyspnea
|
21.1 units on a scale
Standard Deviation 26.1
|
|
Quality of Life Measured by the EORTC QLQ-C30 (Version 3.0)
Symptom scale - Insomnia
|
33.3 units on a scale
Standard Deviation 32.6
|
|
Quality of Life Measured by the EORTC QLQ-C30 (Version 3.0)
Symptom scale - Appetite loss
|
11.6 units on a scale
Standard Deviation 24.1
|
|
Quality of Life Measured by the EORTC QLQ-C30 (Version 3.0)
Symptom scale - Constipation
|
9.72 units on a scale
Standard Deviation 16.8
|
|
Quality of Life Measured by the EORTC QLQ-C30 (Version 3.0)
Symptom scale - Diarrhoea
|
25.7 units on a scale
Standard Deviation 23.1
|
|
Quality of Life Measured by the EORTC QLQ-C30 (Version 3.0)
Symptom scale - Financial difficulties
|
9.93 units on a scale
Standard Deviation 21.9
|
|
Quality of Life Measured by the EORTC QLQ-C30 (Version 3.0)
Global health status / quality-of-life
|
71.2 units on a scale
Standard Deviation 21.6
|
SECONDARY outcome
Timeframe: From treatment start to 24 months after the end of radiotherapyAcute toxicity is defined as toxicity observed within 3 months after treatment initiation. Late toxicity is defined as toxicity observed 3 months after treatment initiation. Here we described the number of patients who observed acute and late toxicities. Details will be given in adverse events description.
Outcome measures
| Measure |
Concomitant Chemotherapy and Radiotherapy
n=70 Participants
Chemoradiotherapy with two cycles of 5FU and Mitomycin-C plus radiotherapy by SIB-IMRT (for simultaneous integrated boost intensity modulated radiation therapy) day 1 to day 50 in 36 fractions
|
|---|---|
|
The Acute and Late Toxicities Assessed According to NCI CTCAE v4.03
Patients with at least one acute toxicity
|
70 Participants
|
|
The Acute and Late Toxicities Assessed According to NCI CTCAE v4.03
Patients with at least one late toxicity
|
43 Participants
|
SECONDARY outcome
Timeframe: at 6 and 12 months after the end of radiotherapyOutcome measures
| Measure |
Concomitant Chemotherapy and Radiotherapy
n=70 Participants
Chemoradiotherapy with two cycles of 5FU and Mitomycin-C plus radiotherapy by SIB-IMRT (for simultaneous integrated boost intensity modulated radiation therapy) day 1 to day 50 in 36 fractions
|
|---|---|
|
The 6- and 12-month Locoregional Control Rates Defined by the Proportion of Patients With no Local Disease Progression at 6 and 12 Months After the End of Radiotherapy
6 months after treatment start
|
61 Participants
|
|
The 6- and 12-month Locoregional Control Rates Defined by the Proportion of Patients With no Local Disease Progression at 6 and 12 Months After the End of Radiotherapy
12 months after treatment start
|
60 Participants
|
SECONDARY outcome
Timeframe: From months 3 to progressionPopulation: Only 62 patients of the 70 included has observed response (complete or partial).
Outcome measures
| Measure |
Concomitant Chemotherapy and Radiotherapy
n=62 Participants
Chemoradiotherapy with two cycles of 5FU and Mitomycin-C plus radiotherapy by SIB-IMRT (for simultaneous integrated boost intensity modulated radiation therapy) day 1 to day 50 in 36 fractions
|
|---|---|
|
Duration of Response Defined by the Time Elapsed From First Objective Response to Progression or Death From Any Cause
|
41.3 month
Standard Deviation 17.2
|
SECONDARY outcome
Timeframe: 6 months after treatment startThe EORTC QLQ-CR29 is a colorectal cancer-specific quality of life module designed to complement the QLQ-C30. It assesses disease- and treatment-related symptoms and functional issues, including urinary frequency, blood and mucus in stool, stool frequency, body image, anxiety, sexual function, and other gastrointestinal and treatment-related symptoms. Scores are linearly transformed to a 0-100 scale; higher functional scores indicate better functioning, whereas higher symptom scores indicate greater symptom burden.
Outcome measures
| Measure |
Concomitant Chemotherapy and Radiotherapy
n=70 Participants
Chemoradiotherapy with two cycles of 5FU and Mitomycin-C plus radiotherapy by SIB-IMRT (for simultaneous integrated boost intensity modulated radiation therapy) day 1 to day 50 in 36 fractions
|
|---|---|
|
Quality of Life Measured by the Additional Colorectal Module QLQ-CR 29
Body image
|
81 units on a scale
Standard Deviation 24.9
|
|
Quality of Life Measured by the Additional Colorectal Module QLQ-CR 29
Anxiety
|
63.9 units on a scale
Standard Deviation 29.5
|
|
Quality of Life Measured by the Additional Colorectal Module QLQ-CR 29
Weight
|
77.6 units on a scale
Standard Deviation 29.2
|
|
Quality of Life Measured by the Additional Colorectal Module QLQ-CR 29
Urinary frequency
|
33 units on a scale
Standard Deviation 20.3
|
|
Quality of Life Measured by the Additional Colorectal Module QLQ-CR 29
Blood and mucus in stool
|
13.9 units on a scale
Standard Deviation 15.7
|
|
Quality of Life Measured by the Additional Colorectal Module QLQ-CR 29
Stool frequency
|
18.3 units on a scale
Standard Deviation 20.9
|
|
Quality of Life Measured by the Additional Colorectal Module QLQ-CR 29
Urinary incontinence
|
5.44 units on a scale
Standard Deviation 14.2
|
|
Quality of Life Measured by the Additional Colorectal Module QLQ-CR 29
Abdominal pain
|
19 units on a scale
Standard Deviation 27.2
|
|
Quality of Life Measured by the Additional Colorectal Module QLQ-CR 29
Buttock pain
|
16.3 units on a scale
Standard Deviation 23.7
|
|
Quality of Life Measured by the Additional Colorectal Module QLQ-CR 29
Bloating
|
23.1 units on a scale
Standard Deviation 26.5
|
|
Quality of Life Measured by the Additional Colorectal Module QLQ-CR 29
Dry mouth
|
19 units on a scale
Standard Deviation 21.5
|
|
Quality of Life Measured by the Additional Colorectal Module QLQ-CR 29
Hair loss
|
25.2 units on a scale
Standard Deviation 29.3
|
|
Quality of Life Measured by the Additional Colorectal Module QLQ-CR 29
Taste
|
12.2 units on a scale
Standard Deviation 25.2
|
|
Quality of Life Measured by the Additional Colorectal Module QLQ-CR 29
Flatulence
|
36.7 units on a scale
Standard Deviation 29
|
|
Quality of Life Measured by the Additional Colorectal Module QLQ-CR 29
Faecal incontinence
|
25.8 units on a scale
Standard Deviation 27.7
|
|
Quality of Life Measured by the Additional Colorectal Module QLQ-CR 29
Sore skin
|
16.2 units on a scale
Standard Deviation 24
|
|
Quality of Life Measured by the Additional Colorectal Module QLQ-CR 29
Embarrassment
|
17.1 units on a scale
Standard Deviation 26.3
|
|
Quality of Life Measured by the Additional Colorectal Module QLQ-CR 29
Impotence
|
29.6 units on a scale
Standard Deviation 26.1
|
|
Quality of Life Measured by the Additional Colorectal Module QLQ-CR 29
Dyspareunia
|
37.5 units on a scale
Standard Deviation 42.1
|
SECONDARY outcome
Timeframe: 6 months after treatment startPopulation: 20 patients did not filled questionnaire at 6 months
Vaizey Score (St. Mark's Incontinence Score): a validated instrument used to assess anal sphincter function and the severity of fecal incontinence. The scale evaluates the frequency of incontinence to gas, liquid, and solid stool, the need to wear pads, use of constipating medication, and lifestyle alterations. Scores range from 0 to 24, with higher scores indicating worse continence and greater impairment of sphincter function.
Outcome measures
| Measure |
Concomitant Chemotherapy and Radiotherapy
n=50 Participants
Chemoradiotherapy with two cycles of 5FU and Mitomycin-C plus radiotherapy by SIB-IMRT (for simultaneous integrated boost intensity modulated radiation therapy) day 1 to day 50 in 36 fractions
|
|---|---|
|
Quality of Life Measured by the Vaizey Incontinence Scale
|
7 units on a scale
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: At 3 months after treatment initiationPopulation: 25 patients did not completed SOMA/LENT subjective questionnaire at 3 months
The Subjective SOMA/LENT (Late Effects on Normal Tissues - Subjective, Objective, Management, and Analytic) scale assesses patient-reported late radiation toxicity across multiple symptom domains. Each symptom item (e.g., stool frequency, urinary frequency, vaginal dryness, dyspareunia) is scored separately on a 5-point ordinal scale ranging from 0 to 4, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms, and 4 = very severe or disabling symptoms. Higher scores indicate worse late radiation-related toxicity. No overall total score was calculated; each symptom domain is reported separately.
Outcome measures
| Measure |
Concomitant Chemotherapy and Radiotherapy
n=45 Participants
Chemoradiotherapy with two cycles of 5FU and Mitomycin-C plus radiotherapy by SIB-IMRT (for simultaneous integrated boost intensity modulated radiation therapy) day 1 to day 50 in 36 fractions
|
|---|---|
|
The Acute Toxicities Assessed According the SOMA/LENT Scale
Stool frequency
|
1.05 units on a scale
Standard Deviation 0.87
|
|
The Acute Toxicities Assessed According the SOMA/LENT Scale
Anal pain during bowel movements
|
0.55 units on a scale
Standard Deviation 0.80
|
|
The Acute Toxicities Assessed According the SOMA/LENT Scale
Tenesmus (false urge to defecate)
|
0.37 units on a scale
Standard Deviation 0.62
|
|
The Acute Toxicities Assessed According the SOMA/LENT Scale
Mucous discharge
|
0.88 units on a scale
Standard Deviation 1.21
|
|
The Acute Toxicities Assessed According the SOMA/LENT Scale
Incontinence
|
0.93 units on a scale
Standard Deviation 1.39
|
|
The Acute Toxicities Assessed According the SOMA/LENT Scale
Bleeding
|
0.21 units on a scale
Standard Deviation 0.61
|
|
The Acute Toxicities Assessed According the SOMA/LENT Scale
Abdominal cramps/spasms
|
0.34 units on a scale
Standard Deviation 0.76
|
|
The Acute Toxicities Assessed According the SOMA/LENT Scale
Urinary frequency
|
0.65 units on a scale
Standard Deviation 0.99
|
|
The Acute Toxicities Assessed According the SOMA/LENT Scale
Hematuria
|
0.02 units on a scale
Standard Deviation 0.15
|
|
The Acute Toxicities Assessed According the SOMA/LENT Scale
Urinary incontinence
|
0.26 units on a scale
Standard Deviation 0.73
|
|
The Acute Toxicities Assessed According the SOMA/LENT Scale
Sensory disturbances
|
0.32 units on a scale
Standard Deviation 0.57
|
|
The Acute Toxicities Assessed According the SOMA/LENT Scale
Vaginal dryness
|
1.09 units on a scale
Standard Deviation 1.35
|
|
The Acute Toxicities Assessed According the SOMA/LENT Scale
Pruritus
|
0.33 units on a scale
Standard Deviation 0.69
|
|
The Acute Toxicities Assessed According the SOMA/LENT Scale
Pain (vulva-vagina)
|
0.30 units on a scale
Standard Deviation 0.59
|
|
The Acute Toxicities Assessed According the SOMA/LENT Scale
Dyspareunia
|
1.04 units on a scale
Standard Deviation 1.64
|
|
The Acute Toxicities Assessed According the SOMA/LENT Scale
Recurrent vaginitis
|
0.13 units on a scale
Standard Deviation 0.55
|
|
The Acute Toxicities Assessed According the SOMA/LENT Scale
Erectile dysfunction
|
0.63 units on a scale
Standard Deviation 0.74
|
Adverse Events
Concomitant Chemotherapy and Radiotherapy
Serious events: 26 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Concomitant Chemotherapy and Radiotherapy
n=70 participants at risk
Chemoradiotherapy with two cycles of 5FU and Mitomycin-C plus radiotherapy by SIB-IMRT (for simultaneous integrated boost intensity modulated radiation therapy) day 1 to day 50 in 36 fractions
5Fluorouracile and Mitomycin-C: All the patients will receive radiochemotherapy with two cycles of 5FU (1,000 mg/m²/d with 96-h infusion, days 1-5 and 29-33 of SIB-IMRT) and Mitomycin-C (10 mg/m², days 1 and 29).
Simultaneously integrated boost of intensity modulated radiation therapy (SIB-IMRT) by tomotherapy: SIB-IMRT schedule of 61.2 Gy/1.7 Gy to the primary tumor, 57.60 Gy / 1.6 Gy to involved nodes, and 54 / 1.5 Gy to elective pelvic lymph nodes.
|
|---|---|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
RADIATION SKIN INJURY
|
2.9%
2/70 • Number of events 4 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
DIARRHOEA
|
7.1%
5/70 • Number of events 6 • From treatment start up to 24 months
|
|
INFECTIONS AND INFESTATIONS
PYELONEPHRITIS
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
LUNG ADENOCARCINOMA
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
METABOLISM AND NUTRITION DISORDERS
DECREASED APPETITE
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
VASCULAR DISORDERS
THROMBOPHLEBITIS
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
DERMATITIS
|
2.9%
2/70 • Number of events 2 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ANAL INFLAMMATION
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
GENERAL PHYSICAL HEALTH DETERIORATION
|
2.9%
2/70 • Number of events 2 • From treatment start up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
GENITAL LABIAL ADHESIONS
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
THROMBOCYTOPENIA
|
4.3%
3/70 • Number of events 3 • From treatment start up to 24 months
|
|
INFECTIONS AND INFESTATIONS
CATHETER SITE INFECTION
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
FEMALE GENITAL TRACT FISTULA
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
LEUKOPENIA
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
FEBRILE NEUTROPENIA
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
INFECTIONS AND INFESTATIONS
ESCHERICHIA URINARY TRACT INFECTION
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
INFECTIONS AND INFESTATIONS
GROIN ABSCESS
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
CARDIAC DISORDERS
ARTERIOSPASM CORONARY
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
SUBILEUS
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
CONSTIPATION
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
GASTROINTESTINAL NECROSIS
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
POST PROCEDURAL DIARRHOEA
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
INVESTIGATIONS
WEIGHT DECREASED
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
INFECTIONS AND INFESTATIONS
SUPERINFECTION
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL PAIN
|
1.4%
1/70 • Number of events 2 • From treatment start up to 24 months
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
ANAEMIA
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
FEBRILE BONE MARROW APLASIA
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ANAL FISTULA
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
FRACTURE
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
RENAL AND URINARY DISORDERS
URINARY INCONTINENCE
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ANAL INCONTINENCE
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
MUCOCUTANEOUS DISORDER
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
METABOLISM AND NUTRITION DISORDERS
HYPOKALAEMIA
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
Other adverse events
| Measure |
Concomitant Chemotherapy and Radiotherapy
n=70 participants at risk
Chemoradiotherapy with two cycles of 5FU and Mitomycin-C plus radiotherapy by SIB-IMRT (for simultaneous integrated boost intensity modulated radiation therapy) day 1 to day 50 in 36 fractions
5Fluorouracile and Mitomycin-C: All the patients will receive radiochemotherapy with two cycles of 5FU (1,000 mg/m²/d with 96-h infusion, days 1-5 and 29-33 of SIB-IMRT) and Mitomycin-C (10 mg/m², days 1 and 29).
Simultaneously integrated boost of intensity modulated radiation therapy (SIB-IMRT) by tomotherapy: SIB-IMRT schedule of 61.2 Gy/1.7 Gy to the primary tumor, 57.60 Gy / 1.6 Gy to involved nodes, and 54 / 1.5 Gy to elective pelvic lymph nodes.
|
|---|---|
|
GASTROINTESTINAL DISORDERS
FREQUENT BOWEL MOVEMENTS
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
INFECTIONS AND INFESTATIONS
DEVICE RELATED INFECTION
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
FISTULA DISCHARGE
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
BACK PAIN
|
4.3%
3/70 • Number of events 3 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
GASTROINTESTINAL PAIN
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
RENAL AND URINARY DISORDERS
POLLAKIURIA
|
30.0%
21/70 • Number of events 22 • From treatment start up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
DERMATITIS DIAPER
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PAIN
|
5.7%
4/70 • Number of events 4 • From treatment start up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
FIBROSIS
|
21.4%
15/70 • Number of events 18 • From treatment start up to 24 months
|
|
INFECTIONS AND INFESTATIONS
FUNGAL SKIN INFECTION
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
CATHETER SITE INFLAMMATION
|
2.9%
2/70 • Number of events 2 • From treatment start up to 24 months
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
LEUKOPENIA
|
8.6%
6/70 • Number of events 6 • From treatment start up to 24 months
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
LYMPHOPENIA
|
10.0%
7/70 • Number of events 7 • From treatment start up to 24 months
|
|
INFECTIONS AND INFESTATIONS
VULVOVAGINAL CANDIDIASIS
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
ULCER
|
2.9%
2/70 • Number of events 2 • From treatment start up to 24 months
|
|
RENAL AND URINARY DISORDERS
MICTURITION DISORDER
|
5.7%
4/70 • Number of events 4 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
DYSCHEZIA
|
5.7%
4/70 • Number of events 4 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
HAEMORRHOIDS
|
7.1%
5/70 • Number of events 5 • From treatment start up to 24 months
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
FEBRILE BONE MARROW APLASIA
|
2.9%
2/70 • Number of events 2 • From treatment start up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
CHILLS
|
4.3%
3/70 • Number of events 4 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
CONSTIPATION
|
12.9%
9/70 • Number of events 9 • From treatment start up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MUCOSAL INFLAMMATION
|
18.6%
13/70 • Number of events 14 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ANAL HAEMORRHAGE
|
2.9%
2/70 • Number of events 2 • From treatment start up to 24 months
|
|
RENAL AND URINARY DISORDERS
URINARY INCONTINENCE
|
15.7%
11/70 • Number of events 11 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ANORECTAL DISCOMFORT
|
8.6%
6/70 • Number of events 7 • From treatment start up to 24 months
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
DYSPNOEA
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
MUCOUS STOOLS
|
8.6%
6/70 • Number of events 6 • From treatment start up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
PELVIC PAIN
|
4.3%
3/70 • Number of events 4 • From treatment start up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
VULVAL DISORDER
|
4.3%
3/70 • Number of events 3 • From treatment start up to 24 months
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MUSCULOSKELETAL PAIN
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
PAIN IN EXTREMITY
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
PSYCHIATRIC DISORDERS
INSOMNIA
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
RADIATION PROCTITIS
|
2.9%
2/70 • Number of events 2 • From treatment start up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
ERYTHEMA
|
4.3%
3/70 • Number of events 3 • From treatment start up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
VULVOVAGINAL INFLAMMATION
|
4.3%
3/70 • Number of events 3 • From treatment start up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
PRURITUS
|
5.7%
4/70 • Number of events 5 • From treatment start up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
SKIN EXFOLIATION
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
INFECTIONS AND INFESTATIONS
ESCHERICHIA INFECTION
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
SKIN REACTION
|
1.4%
1/70 • Number of events 2 • From treatment start up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
PIGMENTATION DISORDER
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
HEADACHE
|
4.3%
3/70 • Number of events 3 • From treatment start up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
VULVOVAGINAL PRURITUS
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
LIP OEDEMA
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
THYROID CANCER
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
INFECTIONS AND INFESTATIONS
VAGINAL INFECTION
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
VULVOVAGINAL DRYNESS
|
4.3%
3/70 • Number of events 3 • From treatment start up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
VAGINAL DISORDER
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
NEURALGIC AMYOTROPHY
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
SCAR INFLAMMATION
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
DYSPAREUNIA
|
8.6%
6/70 • Number of events 6 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ANAL PRURITUS
|
2.9%
2/70 • Number of events 2 • From treatment start up to 24 months
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
COUGH
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
INFECTIONS AND INFESTATIONS
CANDIDA INFECTION
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
RADIATION FIBROSIS
|
2.9%
2/70 • Number of events 2 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ANAL STENOSIS
|
11.4%
8/70 • Number of events 9 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
GASTROINTESTINAL MOTILITY DISORDER
|
2.9%
2/70 • Number of events 2 • From treatment start up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
ERECTILE DYSFUNCTION
|
2.9%
2/70 • Number of events 2 • From treatment start up to 24 months
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
DYSPNOEA EXERTIONAL
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
OEDEMA GENITAL
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
SKIN ULCER
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
SKIN HYPERPIGMENTATION
|
5.7%
4/70 • Number of events 7 • From treatment start up to 24 months
|
|
INFECTIONS AND INFESTATIONS
GENITAL HERPES
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
METABOLISM AND NUTRITION DISORDERS
HYPOKALAEMIA
|
2.9%
2/70 • Number of events 2 • From treatment start up to 24 months
|
|
RENAL AND URINARY DISORDERS
INCONTINENCE
|
4.3%
3/70 • Number of events 4 • From treatment start up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
INTERMENSTRUAL BLEEDING
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
HIATUS HERNIA
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
NEURALGIA
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
TOOTHACHE
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ANAL ULCER
|
2.9%
2/70 • Number of events 2 • From treatment start up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
VAGINAL STRICTURE
|
2.9%
2/70 • Number of events 2 • From treatment start up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
BREAKTHROUGH PAIN
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
SURGICAL AND MEDICAL PROCEDURES
DEPILATION
|
11.4%
8/70 • Number of events 8 • From treatment start up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
SKIN DEPIGMENTATION
|
5.7%
4/70 • Number of events 4 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ANORECTAL SWELLING
|
2.9%
2/70 • Number of events 2 • From treatment start up to 24 months
|
|
INFECTIONS AND INFESTATIONS
FUNGAL INFECTION
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
ATROPHY
|
5.7%
4/70 • Number of events 6 • From treatment start up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
SKIN HYPOPIGMENTATION
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
VULVOVAGINAL PAIN
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
FLATULENCE
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
HEPATOBILIARY DISORDERS
HEPATIC CYTOLYSIS
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
PSYCHIATRIC DISORDERS
ANXIETY
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
PSYCHIATRIC DISORDERS
MOROSE
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
PARAESTHESIA
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
INFECTIONS AND INFESTATIONS
SUBCUTANEOUS ABSCESS
|
1.4%
1/70 • Number of events 2 • From treatment start up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
URTICARIA
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
LOSS OF CONSCIOUSNESS
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
NEUROPATHY PERIPHERAL
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
EOSINOPHILIA
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
INFECTIONS AND INFESTATIONS
BRONCHITIS
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
RENAL AND URINARY DISORDERS
RENAL FAILURE
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
MELAENA
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
RENAL AND URINARY DISORDERS
ACUTE KIDNEY INJURY
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
METABOLISM AND NUTRITION DISORDERS
HYPERCALCAEMIA
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
DEFAECATION DISORDER
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
IMMUNE SYSTEM DISORDERS
CONTRAST MEDIA ALLERGY
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
RECTAL SPASM
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
APHTHOUS ULCER
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
ALOPECIA
|
4.3%
3/70 • Number of events 3 • From treatment start up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
SECRETION DISCHARGE
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ENTERITIS
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
DYSPHAGIA
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
VULVAL ULCERATION
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
NECROSIS
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
EPISTAXIS
|
2.9%
2/70 • Number of events 2 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
PROCTITIS
|
2.9%
2/70 • Number of events 2 • From treatment start up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
SPIDER NAEVUS
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
SKIN DISCOLOURATION
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
RADIATION VULVOVAGINITIS
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MALAISE
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
VASCULAR DISORDERS
HOT FLUSH
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
RADIATION MUCOSITIS
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
DIZZINESS
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
ENDOCRINE DISORDERS
BASEDOW'S DISEASE
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
RECTAL DISCHARGE
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
MOTOR DYSFUNCTION
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
VASCULAR DISORDERS
THROMBOPHLEBITIS
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
GASTROOESOPHAGEAL REFLUX DISEASE
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ODYNOPHAGIA
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
HEPATOBILIARY DISORDERS
CHOLECYSTITIS
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
ANAEMIA
|
18.6%
13/70 • Number of events 14 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
OESOPHAGITIS
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
NEUTROPENIA
|
8.6%
6/70 • Number of events 7 • From treatment start up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PYREXIA
|
11.4%
8/70 • Number of events 8 • From treatment start up to 24 months
|
|
EYE DISORDERS
KERATITIS
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
RENAL AND URINARY DISORDERS
DYSURIA
|
35.7%
25/70 • Number of events 28 • From treatment start up to 24 months
|
|
METABOLISM AND NUTRITION DISORDERS
DECREASED APPETITE
|
22.9%
16/70 • Number of events 16 • From treatment start up to 24 months
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
RADIATION SKIN INJURY
|
45.7%
32/70 • Number of events 36 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
RECTAL HAEMORRHAGE
|
24.3%
17/70 • Number of events 22 • From treatment start up to 24 months
|
|
INVESTIGATIONS
WEIGHT DECREASED
|
14.3%
10/70 • Number of events 10 • From treatment start up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
DERMATITIS
|
44.3%
31/70 • Number of events 32 • From treatment start up to 24 months
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
CYSTITIS RADIATION
|
2.9%
2/70 • Number of events 2 • From treatment start up to 24 months
|
|
INVESTIGATIONS
TRANSAMINASES INCREASED
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
INFECTIONS AND INFESTATIONS
VULVITIS
|
8.6%
6/70 • Number of events 6 • From treatment start up to 24 months
|
|
INFECTIONS AND INFESTATIONS
CYSTITIS
|
2.9%
2/70 • Number of events 2 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ANAL INCONTINENCE
|
27.1%
19/70 • Number of events 22 • From treatment start up to 24 months
|
|
RENAL AND URINARY DISORDERS
MICTURITION URGENCY
|
11.4%
8/70 • Number of events 8 • From treatment start up to 24 months
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
ARTHRALGIA
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL PAIN
|
20.0%
14/70 • Number of events 14 • From treatment start up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
OEDEMA PERIPHERAL
|
4.3%
3/70 • Number of events 3 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
PROCTALGIA
|
32.9%
23/70 • Number of events 28 • From treatment start up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
TELANGIECTASIA
|
28.6%
20/70 • Number of events 28 • From treatment start up to 24 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
SKIN EROSION
|
5.7%
4/70 • Number of events 4 • From treatment start up to 24 months
|
|
VASCULAR DISORDERS
HAEMATOMA
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
DEFAECATION URGENCY
|
2.9%
2/70 • Number of events 2 • From treatment start up to 24 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
ASTHENIA
|
62.9%
44/70 • Number of events 51 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
DIARRHOEA
|
81.4%
57/70 • Number of events 76 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
STOMATITIS
|
2.9%
2/70 • Number of events 2 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
NAUSEA
|
54.3%
38/70 • Number of events 43 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
VOMITING
|
14.3%
10/70 • Number of events 11 • From treatment start up to 24 months
|
|
GASTROINTESTINAL DISORDERS
ANAL INFLAMMATION
|
47.1%
33/70 • Number of events 35 • From treatment start up to 24 months
|
|
NERVOUS SYSTEM DISORDERS
DYSGEUSIA
|
7.1%
5/70 • Number of events 5 • From treatment start up to 24 months
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
THROMBOCYTOPENIA
|
11.4%
8/70 • Number of events 8 • From treatment start up to 24 months
|
|
VASCULAR DISORDERS
HYPERTENSION
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
|
INFECTIONS AND INFESTATIONS
FUNGAL BALANITIS
|
1.4%
1/70 • Number of events 1 • From treatment start up to 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place