Trial Outcomes & Findings for Study of ADXS11-001 in Participants With High Risk Locally Advanced Cervical Cancer (NCT NCT02853604)
NCT ID: NCT02853604
Last Updated: 2023-03-14
Results Overview
DFS was defined as the time from randomization until death or recurrence. The date of recurrence was defined as the date of the first time point when recurrence of disease was determined. The determination of recurrence should occur by definitive pathologic tissue confirmation (e.g., biopsy/fine needle aspirate). However, in those cases where it was not medically feasible to obtain a tissue sample then radiographic evidence, when confirmed by independent radiology review, was used to determine recurrence.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
110 participants
Primary outcome timeframe
From the time of randomization to recurrence or death (Maximum duration: 44.7 months)
Results posted on
2023-03-14
Participant Flow
Participants with high-risk disease as determined by prognostic factors such as tumor staging, nodal involvement, extent of nodal involvement, and location of nodal involvement were enrolled in this study.
Participants completed cisplatin-based combination chemotherapy and radiation (CCRT) before enrollment into the study.
Participant milestones
| Measure |
Placebo
Participants with locally advanced cervical cancer at higher risk for recurrence (HRLACC) received ADXS11-001 matching placebo by intravenous infusion for approximately 60 minutes every 3 weeks for 3 doses (Weeks 1, 4 and 7) and thereafter, every 8 weeks for 5 doses (Weeks 15, 23, 31, 39, and 47) during treatment phase or until disease recurrence. Participants received a 7-day course placebo matching to either trimethoprim/sulfamethoxazole or ampicillin starting 72 hours post treatment in prime and maintenance phase.
|
ADXS11-001
Participants with HRLACC received ADXS11-001 at a dose of 1x10\^9 colony forming units (CFU) by intravenous infusion for approximately 60 minutes every 3 weeks for 3 doses (Weeks 1, 4 and 7) and thereafter, every 8 weeks for 5 doses (Weeks 15, 23, 31, 39, and 47) during treatment phase or until disease recurrence. Participants received a 7-day course of either trimethoprim/sulfamethoxazole or ampicillin starting 72 hours post treatment in prime and maintenance phase.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
73
|
|
Overall Study
Treated
|
37
|
72
|
|
Overall Study
COMPLETED
|
9
|
21
|
|
Overall Study
NOT COMPLETED
|
28
|
52
|
Reasons for withdrawal
| Measure |
Placebo
Participants with locally advanced cervical cancer at higher risk for recurrence (HRLACC) received ADXS11-001 matching placebo by intravenous infusion for approximately 60 minutes every 3 weeks for 3 doses (Weeks 1, 4 and 7) and thereafter, every 8 weeks for 5 doses (Weeks 15, 23, 31, 39, and 47) during treatment phase or until disease recurrence. Participants received a 7-day course placebo matching to either trimethoprim/sulfamethoxazole or ampicillin starting 72 hours post treatment in prime and maintenance phase.
|
ADXS11-001
Participants with HRLACC received ADXS11-001 at a dose of 1x10\^9 colony forming units (CFU) by intravenous infusion for approximately 60 minutes every 3 weeks for 3 doses (Weeks 1, 4 and 7) and thereafter, every 8 weeks for 5 doses (Weeks 15, 23, 31, 39, and 47) during treatment phase or until disease recurrence. Participants received a 7-day course of either trimethoprim/sulfamethoxazole or ampicillin starting 72 hours post treatment in prime and maintenance phase.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
12
|
35
|
|
Overall Study
Lost to Follow-up
|
4
|
8
|
|
Overall Study
Death
|
1
|
5
|
|
Overall Study
Miscellaneous
|
11
|
2
|
|
Overall Study
Progressive Disease
|
0
|
2
|
Baseline Characteristics
Study of ADXS11-001 in Participants With High Risk Locally Advanced Cervical Cancer
Baseline characteristics by cohort
| Measure |
Placebo
n=37 Participants
Participants with HRLACC received ADXS11-001 matching placebo by intravenous infusion for approximately 60 minutes every 3 weeks for 3 doses (Weeks 1, 4 and 7) and thereafter, every 8 weeks for 5 doses (Weeks 15, 23, 31, 39, and 47) during treatment phase or until disease recurrence. Participants received a 7-day course placebo matching to either trimethoprim/sulfamethoxazole or ampicillin starting 72 hours post treatment in prime and maintenance phase.
|
ADXS11-001
n=72 Participants
Participants with HRLACC received ADXS11-001 at a dose of 1x10\^9 CFU by intravenous infusion for approximately 60 minutes every 3 weeks for 3 doses (Weeks 1, 4 and 7) and thereafter, every 8 weeks for 5 doses (Weeks 15, 23, 31, 39, and 47) during treatment phase or until disease recurrence. Participants received a 7-day course of either trimethoprim/sulfamethoxazole or ampicillin starting 72 hours post treatment in prime and maintenance phase.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.0 years
STANDARD_DEVIATION 10.34 • n=99 Participants
|
49.3 years
STANDARD_DEVIATION 10.61 • n=107 Participants
|
48.2 years
STANDARD_DEVIATION 10.59 • n=206 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From the time of randomization to recurrence or death (Maximum duration: 44.7 months)Population: This endpoint was not reported as the study was terminated early due to business reasons, therefore, no efficacy data was collected.
DFS was defined as the time from randomization until death or recurrence. The date of recurrence was defined as the date of the first time point when recurrence of disease was determined. The determination of recurrence should occur by definitive pathologic tissue confirmation (e.g., biopsy/fine needle aspirate). However, in those cases where it was not medically feasible to obtain a tissue sample then radiographic evidence, when confirmed by independent radiology review, was used to determine recurrence.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of study drug until end of study (Up to 44.7 months)Population: AT Population
Adverse event (AE): any untoward medical occurrence in a participant administered a study treatment \& which did not necessarily have to have a causal relationship with the study treatment. An AE is, any unfavorable \& unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of study treatment. AE with onset dates on or after the first dose of study treatment were considered treatment emergent.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants with HRLACC received ADXS11-001 matching placebo by intravenous infusion for approximately 60 minutes every 3 weeks for 3 doses (Weeks 1, 4 and 7) and thereafter, every 8 weeks for 5 doses (Weeks 15, 23, 31, 39, and 47) during treatment phase or until disease recurrence. Participants received a 7-day course placebo matching to either trimethoprim/sulfamethoxazole or ampicillin starting 72 hours post treatment in prime and maintenance phase.
|
ADXS11-001
n=72 Participants
Participants with HRLACC received ADXS11-001 at a dose of 1x10\^9 CFU by intravenous infusion for approximately 60 minutes every 3 weeks for 3 doses (Weeks 1, 4 and 7) and thereafter, every 8 weeks for 5 doses (Weeks 15, 23, 31, 39, and 47) during treatment phase or until disease recurrence. Participants received a 7-day course of either trimethoprim/sulfamethoxazole or ampicillin starting 72 hours post treatment in prime and maintenance phase.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
|
30 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: From the date of randomization until death due to any cause (Maximum duration: 44.7 months)Population: This endpoint was not reported as the study was terminated early due to business reasons, therefore, no efficacy data was collected.
Overall survival was defined as the time from the date of randomization until death due to any cause.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 30 other events
Deaths: 1 deaths
ADXS11-001
Serious events: 10 serious events
Other events: 62 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Placebo
n=37 participants at risk
Participants with HRLACC received ADXS11-001 matching placebo by intravenous infusion for approximately 60 minutes every 3 weeks for 3 doses (Weeks 1, 4 and 7) and thereafter, every 8 weeks for 5 doses (Weeks 15, 23, 31, 39, and 47) during treatment phase until or disease recurrence. Participants received a 7-day course placebo matching to either trimethoprim/sulfamethoxazole or ampicillin starting 72 hours post treatment in prime and maintenance phase.
|
ADXS11-001
n=72 participants at risk
Participants with HRLACC received ADXS11-001 at a dose of 1x10\^9 CFU by intravenous infusion for approximately 60 minutes every 3 weeks for 3 doses (Weeks 1, 4 and 7) and thereafter, every 8 weeks for 5 doses (Weeks 15, 23, 31, 39, and 47) during treatment phase or until disease recurrence. Participants received a 7-day course of either trimethoprim/sulfamethoxazole or ampicillin starting 72 hours post treatment in prime and maintenance phase.
|
|---|---|---|
|
Gastrointestinal disorders
Colitis
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
General disorders
Chest discomfort
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
2.8%
2/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Infections and infestations
Kidney infection
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Injury, poisoning and procedural complications
Radiation proctitis
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Vascular disorders
Hypotension
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
Other adverse events
| Measure |
Placebo
n=37 participants at risk
Participants with HRLACC received ADXS11-001 matching placebo by intravenous infusion for approximately 60 minutes every 3 weeks for 3 doses (Weeks 1, 4 and 7) and thereafter, every 8 weeks for 5 doses (Weeks 15, 23, 31, 39, and 47) during treatment phase until or disease recurrence. Participants received a 7-day course placebo matching to either trimethoprim/sulfamethoxazole or ampicillin starting 72 hours post treatment in prime and maintenance phase.
|
ADXS11-001
n=72 participants at risk
Participants with HRLACC received ADXS11-001 at a dose of 1x10\^9 CFU by intravenous infusion for approximately 60 minutes every 3 weeks for 3 doses (Weeks 1, 4 and 7) and thereafter, every 8 weeks for 5 doses (Weeks 15, 23, 31, 39, and 47) during treatment phase or until disease recurrence. Participants received a 7-day course of either trimethoprim/sulfamethoxazole or ampicillin starting 72 hours post treatment in prime and maintenance phase.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.1%
3/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
19.4%
14/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.4%
2/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
5.6%
4/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
4.2%
3/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Blood and lymphatic system disorders
Monocytopenia
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
6.9%
5/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
2.8%
2/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
11.1%
8/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Eye disorders
Eye irritation
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
2.8%
2/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Abdominal pain
|
16.2%
6/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
11.1%
8/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
2.8%
2/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Colitis
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Constipation
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
5.6%
4/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Diarrhoea
|
18.9%
7/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
4.2%
3/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Dyspepsia
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
2.8%
2/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Faeces soft
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Glossodynia
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
4.2%
3/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Nausea
|
10.8%
4/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
27.8%
20/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
8.1%
3/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
2.8%
2/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
13.9%
10/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
General disorders
Asthenia
|
8.1%
3/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
General disorders
Chest discomfort
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
General disorders
Chills
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
31.9%
23/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
General disorders
Discomfort
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
General disorders
Fatigue
|
10.8%
4/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
18.1%
13/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
General disorders
Feeling cold
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
General disorders
Hyperthermia
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
15.3%
11/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
General disorders
Influenza like illness
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
4.2%
3/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
General disorders
Localised oedema
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
General disorders
Malaise
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
2.8%
2/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
General disorders
Oedema peripheral
|
10.8%
4/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
General disorders
Pain
|
5.4%
2/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
4.2%
3/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
General disorders
Peripheral swelling
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
General disorders
Pyrexia
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
37.5%
27/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Hepatobiliary disorders
Ocular icterus
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Immune system disorders
Cytokine release syndrome
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
15.3%
11/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Infections and infestations
Cystitis
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Infections and infestations
Ear infection
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Infections and infestations
Influenza
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Infections and infestations
Kidney infection
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Infections and infestations
Sinusitis
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
4.2%
3/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Immune system disorders
Upper respiratory tract infection
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
2.8%
2/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
4.2%
3/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Infections and infestations
Vaginal infection
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Infections and infestations
Viral sinusitis
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.4%
2/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Injury, poisoning and procedural complications
Drug administration error
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
4.2%
3/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Injury, poisoning and procedural complications
Radiation proctitis
|
5.4%
2/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
2.8%
2/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Investigations
Alanine aminotransferase increased
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Investigations
Aspartate aminotransferase increased
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
2.8%
2/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Investigations
Blood chloride decreased
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
4.2%
3/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Investigations
Blood pressure increased
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
2.8%
2/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Investigations
Blood urea increased
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Investigations
Body temperature increased
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Investigations
C-reactive protein increased
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
8.3%
6/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Investigations
Lymphocyte count decreased
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
2.8%
2/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Investigations
Mean cell haemoglobin decreased
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Investigations
Mean cell volume decreased
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Investigations
Weight decreased
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
2.8%
2/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Investigations
Weight increased
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Investigations
White blood cell count decreased
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
2.8%
2/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
2.8%
2/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
2.8%
2/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.8%
4/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
9.7%
7/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.4%
2/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
9.7%
7/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
2.8%
2/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.4%
2/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
8.3%
6/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.4%
2/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Nervous system disorders
Dizziness
|
5.4%
2/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
5.6%
4/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Nervous system disorders
Headache
|
18.9%
7/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
27.8%
20/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Nervous system disorders
Hypoaesthesia
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Nervous system disorders
Migraine
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Nervous system disorders
Neuropathy peripheral
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Nervous system disorders
Tremor
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
2.8%
2/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Psychiatric disorders
Anxiety
|
5.4%
2/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
5.6%
4/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Psychiatric disorders
Insomnia
|
5.4%
2/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Psychiatric disorders
Irritability
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Renal and urinary disorders
Bladder pain
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
4.2%
3/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Renal and urinary disorders
Hydronephrosis
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Renal and urinary disorders
Micturition urgency
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Renal and urinary disorders
Pollakiuria
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Renal and urinary disorders
Proteinuria
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Renal and urinary disorders
Ureteric dilatation
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Renal and urinary disorders
Urinary incontinence
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Reproductive system and breast disorders
Cervix inflammation
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Reproductive system and breast disorders
Coital bleeding
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Reproductive system and breast disorders
Dyspareunia
|
5.4%
2/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
2.8%
2/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Reproductive system and breast disorders
Hydrometra
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
5.6%
4/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Reproductive system and breast disorders
Uterine pain
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Reproductive system and breast disorders
Vaginal discharge
|
5.4%
2/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
4.2%
3/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Reproductive system and breast disorders
Vaginal fistula
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
5.4%
2/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Reproductive system and breast disorders
Vulvovaginal adhesion
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.4%
2/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
2.8%
2/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.4%
2/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
0.00%
0/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.7%
1/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
4.2%
3/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.1%
3/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Vascular disorders
Flushing
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
2.8%
2/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Vascular disorders
Hot flush
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Vascular disorders
Hypertension
|
5.4%
2/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
5.6%
4/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Vascular disorders
Hypotension
|
13.5%
5/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
19.4%
14/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Vascular disorders
Pallor
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
General disorders
Infusion site extravasation
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
1.4%
1/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/37 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
2.8%
2/72 • From first dose of study drug until end of study (Up to 44.7 months)
AT Population
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator shall seek the Sponsor's written approval for study results publication which shall not be unreasonably withheld. Such publication by Institution and/or Investigator may be no earlier than after a cooperative publication has been published with Sponsor or 1 year from date of completion or termination of the Study \& only after review and comment by Sponsor. Institution agrees to provide Sponsor a copy of proposed publication at least 60 days prior to submission to a publisher.
- Publication restrictions are in place
Restriction type: OTHER