Trial Outcomes & Findings for Study of Axitinib for Reducing Extent of Venous Tumour Thrombus in Renal Cancer With Venous Invasion (NCT NCT03494816)
NCT ID: NCT03494816
Last Updated: 2021-06-30
Results Overview
The number and percentage of evaluable patients with a change in the Mayo Classification. A patient is defined as a responder if their Mayo level is lower at 9 weeks as compared to baseline; all other patients are defined as non-responders. The Mayo Classification levels are defined as follows, ordered by increasing severity: * Level 0: thrombus limited to the renal vein * Level 1: into IVC \<2cm from renal vein ostium level * Level 2: IVC extension \>2cm from renal vein ostium and below hepatic vein * Level 3: thrombus at the level of or above the hepatic veins but below the diaphragm * Level 4: thrombus extending above the diaphragm
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Surgery and radiology assessment at week 9 in comparison to pre-axitinib assessment.
Results posted on
2021-06-30
Participant Flow
Participant milestones
| Measure |
Single Arm
Axitinib - oral tablet twice daily for 8 weeks prior to surgery. Starting dose 5mg.
Axitinib Oral Tablet: Axitinib is an oral VEGF-receptor inhibitor. Patients are prescribed a starting dose of 5mg twice daily, escalating to 10mg in absence of dose limiting toxicities and blood pressure.
Doses should be taken approximately 12 hours apart and patients should be instructed to take their doses at approximately the same times each day with or without food as per instruction. On clinic days only, patients will be advised to fast for 6 hours prior to their clinic visit.
Patients should be advised to stop axitinib treatment a minimum of 36 hours and maximum of 7 days prior to week 9 nephrectomy and thrombectomy surgery.
Dose adjustments, including dose increase or dose reduction, are permitted and should be based on clinical judgement and the guidelines provided in the protocol.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Single Arm
Axitinib - oral tablet twice daily for 8 weeks prior to surgery. Starting dose 5mg.
Axitinib Oral Tablet: Axitinib is an oral VEGF-receptor inhibitor. Patients are prescribed a starting dose of 5mg twice daily, escalating to 10mg in absence of dose limiting toxicities and blood pressure.
Doses should be taken approximately 12 hours apart and patients should be instructed to take their doses at approximately the same times each day with or without food as per instruction. On clinic days only, patients will be advised to fast for 6 hours prior to their clinic visit.
Patients should be advised to stop axitinib treatment a minimum of 36 hours and maximum of 7 days prior to week 9 nephrectomy and thrombectomy surgery.
Dose adjustments, including dose increase or dose reduction, are permitted and should be based on clinical judgement and the guidelines provided in the protocol.
|
|---|---|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Did not start trial treatment
|
1
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Study of Axitinib for Reducing Extent of Venous Tumour Thrombus in Renal Cancer With Venous Invasion
Baseline characteristics by cohort
| Measure |
ITT Population
n=24 Participants
The Intention-to-treat (ITT) population includes all patients registered onto the study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 7.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Surgery and radiology assessment at week 9 in comparison to pre-axitinib assessment.The number and percentage of evaluable patients with a change in the Mayo Classification. A patient is defined as a responder if their Mayo level is lower at 9 weeks as compared to baseline; all other patients are defined as non-responders. The Mayo Classification levels are defined as follows, ordered by increasing severity: * Level 0: thrombus limited to the renal vein * Level 1: into IVC \<2cm from renal vein ostium level * Level 2: IVC extension \>2cm from renal vein ostium and below hepatic vein * Level 3: thrombus at the level of or above the hepatic veins but below the diaphragm * Level 4: thrombus extending above the diaphragm
Outcome measures
| Measure |
Evaluable Patients
n=21 Participants
The evaluable population includes all patients in the ITT population who have received at least one dose of the study drug (including any patients who were enrolled in error, received study drug and were subsequently found to be ineligible).
|
|---|---|
|
Number of Patients With a Change in Mayo Classification
Responder
|
6 Participants
|
|
Number of Patients With a Change in Mayo Classification
Non-responder
|
15 Participants
|
SECONDARY outcome
Timeframe: Surgical planning will be conducted at week 1 (prior to axitinib) and compared to the actual outcome at week 9.The percentage of patients with a change in surgical management. Tumour thrombus surgical management approaches are provided below, ordered by increasing invasiveness: 1. Thrombus - Milked back into renal vein and side clamped 2. Infra-hepatic (IVC clamping with no liver mobilisation) 3. Retro-hepatic (liver mobilisation and clamping below hepatic veins) 4. Retro-hepatic (liver mobilisation and clamping above hepatic veins) 5. Supra-hepatic (infradiaphragmatic) 6. Supra-hepatic (supradiaphragmatic)
Outcome measures
| Measure |
Evaluable Patients
n=17 Participants
The evaluable population includes all patients in the ITT population who have received at least one dose of the study drug (including any patients who were enrolled in error, received study drug and were subsequently found to be ineligible).
|
|---|---|
|
% Patients With Change in Surgical Management
Improvement in control of IVC/renal vein
|
6 Participants
|
|
% Patients With Change in Surgical Management
Deterioration in control of IVC/renal vein
|
0 Participants
|
|
% Patients With Change in Surgical Management
No change in control of IVC/renal vein
|
11 Participants
|
SECONDARY outcome
Timeframe: Radiology assessment- The VTT height will be measured prior to axitinib and compared with the VTT height just before surgery (week 9). Both pre-axitinib and week 9 scans will be centrally reviewed by the lead NAXIVA radiologists prior to analysis.The percentage change in VTT height. VTT height is measured as follows: if the size of the tumour is X at baseline and Y at the later timepoint, the reduction value is calculated as follows: 1-(Y/X). Therefore, positive values indicate a reduction and negative values indicate an increase.
Outcome measures
| Measure |
Evaluable Patients
n=17 Participants
The evaluable population includes all patients in the ITT population who have received at least one dose of the study drug (including any patients who were enrolled in error, received study drug and were subsequently found to be ineligible).
|
|---|---|
|
Change in Venous Tumour Thrombus (VTT) Height
|
21.49 percentage decrease in VTT length
Standard Deviation 27.60
|
SECONDARY outcome
Timeframe: Radiology assessment- The response rate (RECIST) will be assessed at week 9 in comparison to pre-axitinib measurements.Both pre-axitinib and week 9 scans will be centrally reviewed by the lead NAXIVA radiologists prior to analysis.Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI. In summary, the RECIST v1.1 response categories are: * Complete Response (CR): disappearance of all target lesions * Partial Response (PR): \>=30% decrease in the sum of the longest diameter of target lesions * Progressive Disease (PD): \>=20% increase in the sum of diameters of target lesions AND an absolute increase of \>5mm (or the appearence of 1+ new lesions) * Stable Disease (SD): neither sufficient shrinkage to for PR nor sufficient increase for PD Eisenhauer et al., 2009. Eur J Cancer; 45(2): 228-47.
Outcome measures
| Measure |
Evaluable Patients
n=18 Participants
The evaluable population includes all patients in the ITT population who have received at least one dose of the study drug (including any patients who were enrolled in error, received study drug and were subsequently found to be ineligible).
|
|---|---|
|
Number of Patients With RECIST Responses
Complete response
|
0 Participants
|
|
Number of Patients With RECIST Responses
Partial response
|
3 Participants
|
|
Number of Patients With RECIST Responses
Stable disease
|
13 Participants
|
|
Number of Patients With RECIST Responses
Progressive disease
|
2 Participants
|
|
Number of Patients With RECIST Responses
Non-evaluable
|
0 Participants
|
SECONDARY outcome
Timeframe: Morbidity rates will be assessed by radiology assessment using pre-axitinib and week 9 scans. Both pre-axitinib and week 9 scans will be centrally reviewed by the lead NAXIVA radiologists prior to analysis.Morbidity will be measured according to the Clavien-Dindo classification. A summary of the relevant categories is as follows: Grade I: Any deviation from the normal post-operative course not requiring surgical, endoscopic or radiological intervention (inc. certain drugs, physiotherapy and wound infections that are opened at the bedside) Grade II: Complications requiring drug treatments other than those allowed for Grade I complications (inc. blood transfusion and total parenteral nutrition (TPN)) Grade III: Complications requiring surgical, endoscopic or radiological intervention (IIIa=not under general anaesthetic/IIIb=under general anaesthetic) Grade IV: Life-threatening complications (inc. CNS complications requiring intensive care, but excludes transient ischaemic attacks (TIAs)) (IVa=single-organ dysfunction (inc. dialysis)/IVb=multi-organ dysfunction) Grade V: Death of the patient Dindo et al., 2004. Ann Surg;240(2):205-13.
Outcome measures
| Measure |
Evaluable Patients
n=6 Participants
The evaluable population includes all patients in the ITT population who have received at least one dose of the study drug (including any patients who were enrolled in error, received study drug and were subsequently found to be ineligible).
|
|---|---|
|
Surgical Complication Rates
Grade I
|
1 Participants
|
|
Surgical Complication Rates
Grade II
|
3 Participants
|
|
Surgical Complication Rates
Grade IIIa
|
0 Participants
|
|
Surgical Complication Rates
Grade IIIb
|
0 Participants
|
|
Surgical Complication Rates
Grade IVa
|
0 Participants
|
|
Surgical Complication Rates
Grade IVb
|
1 Participants
|
|
Surgical Complication Rates
Grade V
|
1 Participants
|
Adverse Events
ITT Population
Serious events: 8 serious events
Other events: 24 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
ITT Population
n=24 participants at risk
The Intention-to-treat (ITT) population includes all patients registered onto the study.
|
|---|---|
|
Injury, poisoning and procedural complications
Wound complication
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pathological fracture
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nervous system neoplasms malignant and unspecified NEC
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Cardiac disorders
Cardiac arrest
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Nervous system disorders
Myasthenia gravis
|
4.2%
1/24 • Number of events 2 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Nervous system disorders
Middle cerebral artery infarct
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Psychiatric disorders
Confusional state
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Renal and urinary disorders
Hematuria
|
8.3%
2/24 • Number of events 2 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Renal and urinary disorders
Urinary retention
|
4.2%
1/24 • Number of events 2 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Endocrine disorders
Hyperglycemia
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
Other adverse events
| Measure |
ITT Population
n=24 participants at risk
The Intention-to-treat (ITT) population includes all patients registered onto the study.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
29.2%
7/24 • Number of events 13 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Metabolism and nutrition disorders
Adrenal insufficiency
|
4.2%
1/24 • Number of events 2 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
3/24 • Number of events 5 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Blood and lymphatic system disorders
Anemia
|
8.3%
2/24 • Number of events 3 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Psychiatric disorders
Anxiety
|
8.3%
2/24 • Number of events 5 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
3/24 • Number of events 7 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
General disorders
Asthenia
|
8.3%
2/24 • Number of events 2 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
8/24 • Number of events 13 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Investigations
Blood creatinine increased
|
8.3%
2/24 • Number of events 4 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Cardiac disorders
Cardiac murmur
|
4.2%
1/24 • Number of events 2 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Cardiac disorders
Chest pain
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
8/24 • Number of events 13 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
6/24 • Number of events 14 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Ear and labyrinth disorders
Deafness
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
2/24 • Number of events 2 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
8/24 • Number of events 14 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Nervous system disorders
Dizziness
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
6/24 • Number of events 15 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
4/24 • Number of events 9 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
4/24 • Number of events 11 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Psychiatric disorders
Dysphonia
|
41.7%
10/24 • Number of events 30 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Cardiac disorders
Dyspnea exertional
|
12.5%
3/24 • Number of events 6 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Renal and urinary disorders
Dysuria
|
12.5%
3/24 • Number of events 4 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Vascular disorders
Epistaxis
|
12.5%
3/24 • Number of events 3 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
General disorders
Fatigue
|
62.5%
15/24 • Number of events 47 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
General disorders
Flank pain
|
4.2%
1/24 • Number of events 2 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
4.2%
1/24 • Number of events 2 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Nervous system disorders
Headache
|
12.5%
3/24 • Number of events 4 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Reproductive system and breast disorders
Hematuria
|
12.5%
3/24 • Number of events 5 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.3%
2/24 • Number of events 3 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.3%
2/24 • Number of events 3 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Vascular disorders
Hypertension
|
79.2%
19/24 • Number of events 85 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Nervous system disorders
Hypoesthesia
|
4.2%
1/24 • Number of events 2 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.2%
1/24 • Number of events 3 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Vascular disorders
Hypotension
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
4/24 • Number of events 6 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
General disorders
Incision site pain
|
4.2%
1/24 • Number of events 2 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Psychiatric disorders
Insomnia
|
29.2%
7/24 • Number of events 16 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Eye disorders
Lacrimation increased
|
4.2%
1/24 • Number of events 6 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
General disorders
Lethargy
|
4.2%
1/24 • Number of events 2 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
General disorders
Loose tooth
|
4.2%
1/24 • Number of events 2 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Investigations
Male genital examination abnormal
|
4.2%
1/24 • Number of events 5 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Nervous system disorders
Migraine
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
General disorders
Mucosal inflammation
|
37.5%
9/24 • Number of events 21 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Nervous system disorders
Muscular weakness
|
25.0%
6/24 • Number of events 13 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
3/24 • Number of events 6 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Nervous system disorders
Myasthenia gravis
|
4.2%
1/24 • Number of events 4 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Gastrointestinal disorders
Nausea
|
29.2%
7/24 • Number of events 17 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Nervous system disorders
Neuropathy peripheral
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
General disorders
Night sweats
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Renal and urinary disorders
Nocturia
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Gastrointestinal disorders
Oral candidiasis
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Gastrointestinal disorders
Oral pain
|
8.3%
2/24 • Number of events 6 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
General disorders
Pain
|
4.2%
1/24 • Number of events 4 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
2/24 • Number of events 4 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
12.5%
3/24 • Number of events 10 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Nervous system disorders
Paraesthesia
|
8.3%
2/24 • Number of events 2 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Infections and infestations
Pathological fracture
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Renal and urinary disorders
Pollakiuria
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Infections and infestations
Postoperative wound infection
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Renal and urinary disorders
Proteinuria
|
41.7%
10/24 • Number of events 25 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
2/24 • Number of events 2 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.2%
1/24 • Number of events 2 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
General disorders
Pyrexia
|
8.3%
2/24 • Number of events 2 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
2/24 • Number of events 4 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Renal and urinary disorders
Renal pain
|
4.2%
1/24 • Number of events 3 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Infections and infestations
Respiratory tract infection viral
|
8.3%
2/24 • Number of events 2 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Cardiac disorders
Sinus tachycardia
|
8.3%
2/24 • Number of events 4 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
3/24 • Number of events 4 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Renal and urinary disorders
Urinary tract infection
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Eye disorders
Vitreous floaters
|
4.2%
1/24 • Number of events 1 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
4/24 • Number of events 7 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
|
Investigations
Weight decreased
|
25.0%
6/24 • Number of events 14 • Data were collected at screening, Week 1, Week 3, Week 5, Week 7, Week 9 (srugery), 6 weeks post-surgery, 12 weeks post-surgery.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place