Trial Outcomes & Findings for A Phase II Clinical Trial Evaluating the Combination of Olaparib and Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma (NCT NCT03880019)
NCT ID: NCT03880019
Last Updated: 2025-12-03
Results Overview
Will be measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria assessed by MRI: Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm); Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. A response rate of 10% is considered inactive and unworthy of further study. A response rate of 35% would be promising for further study among patients with advanced uterine leiomyosarcoma (LMS) treated with at least one prior systemic regimen. A response rate of 35% for the temozolomide (TMZ) + poly(adenosine diphosphate\[ADP\]-ribose) polymerase inhibitor (PARPi) combination would also be suggestive of superior efficacy over TMZ monotherapy in sarcoma. Will be reported with a 95% confidence interval.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Within first 6 months of study treatment
Results posted on
2025-12-03
Participant Flow
One enrolled patient did not begin treatment.
Participant milestones
| Measure |
Treatment (Olaparib, Temozolomide)
Patients receive olaparib PO BID and temozolomide PO QD on days 1-7. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI once every 2 cycles. For patients who continue beyond 12 cycles, MRI or CT imaging may be changed to once every 4 cycles. Patients undergo tumor biopsy cycle 2 days 3-5.
\>
\> Computed Tomography: Undergo CT
\>
\> Core Biopsy: Undergo tumor biopsy
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Olaparib: Given orally (PO)
\>
\> Temozolomide: Given PO
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Olaparib, Temozolomide)
Patients receive olaparib PO BID and temozolomide PO QD on days 1-7. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI once every 2 cycles. For patients who continue beyond 12 cycles, MRI or CT imaging may be changed to once every 4 cycles. Patients undergo tumor biopsy cycle 2 days 3-5.
\>
\> Computed Tomography: Undergo CT
\>
\> Core Biopsy: Undergo tumor biopsy
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Olaparib: Given orally (PO)
\>
\> Temozolomide: Given PO
|
|---|---|
|
Overall Study
Competing disease
|
1
|
Baseline Characteristics
A Phase II Clinical Trial Evaluating the Combination of Olaparib and Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma
Baseline characteristics by cohort
| Measure |
Treatment (Olaparib, Temozolomide)
n=22 Participants
Patients receive olaparib PO BID and temozolomide PO QD on days 1-7. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI once every 2 cycles. For patients who continue beyond 12 cycles, MRI or CT imaging may be changed to once every 4 cycles. Patients undergo tumor biopsy cycle 2 days 3-5.\>
\> Computed Tomography: Undergo CT\>
\> Core Biopsy: Undergo tumor biopsy\>
\> Magnetic Resonance Imaging: Undergo MRI\>
\> Olaparib: Given orally (PO)\>
\> Temozolomide: Given PO
|
|---|---|
|
Age, Continuous
|
55 years
n=3 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=3 Participants
|
|
Stage at Study Entry
Locally advanced/unresectable
|
3 Participants
n=3 Participants
|
|
Stage at Study Entry
Metastatic
|
17 Participants
n=3 Participants
|
|
Stage at Study Entry
Unknown
|
2 Participants
n=3 Participants
|
|
Prior Lines of Treatment
1-2
|
9 Participants
n=3 Participants
|
|
Prior Lines of Treatment
3 or more
|
13 Participants
n=3 Participants
|
|
ECOG Performance Status
0
|
7 Participants
n=3 Participants
|
|
ECOG Performance Status
1
|
15 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Within first 6 months of study treatmentWill be measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria assessed by MRI: Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm); Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. A response rate of 10% is considered inactive and unworthy of further study. A response rate of 35% would be promising for further study among patients with advanced uterine leiomyosarcoma (LMS) treated with at least one prior systemic regimen. A response rate of 35% for the temozolomide (TMZ) + poly(adenosine diphosphate\[ADP\]-ribose) polymerase inhibitor (PARPi) combination would also be suggestive of superior efficacy over TMZ monotherapy in sarcoma. Will be reported with a 95% confidence interval.
Outcome measures
| Measure |
Treatment (Olaparib, Temozolomide)
n=22 Participants
Patients receive olaparib PO BID and temozolomide PO QD on days 1-7. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI once every 2 cycles. For patients who continue beyond 12 cycles, MRI or CT imaging may be changed to once every 4 cycles. Patients undergo tumor biopsy cycle 2 days 3-5.
\>
\> Computed Tomography: Undergo CT
\>
\> Core Biopsy: Undergo tumor biopsy
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Olaparib: Given orally (PO)
\>
\> Temozolomide: Given PO
|
|---|---|
|
Confirmed Objective Response Rate (ORR) (Complete Response + Partial Response)
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years after study treatmentRecorded at each clinical visit and will be categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Number of patients experiencing a grade 3 or greater adverse event will be reported.
Outcome measures
| Measure |
Treatment (Olaparib, Temozolomide)
n=22 Participants
Patients receive olaparib PO BID and temozolomide PO QD on days 1-7. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI once every 2 cycles. For patients who continue beyond 12 cycles, MRI or CT imaging may be changed to once every 4 cycles. Patients undergo tumor biopsy cycle 2 days 3-5.
\>
\> Computed Tomography: Undergo CT
\>
\> Core Biopsy: Undergo tumor biopsy
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Olaparib: Given orally (PO)
\>
\> Temozolomide: Given PO
|
|---|---|
|
Number of Patients Experiencing Adverse Events
|
20 Participants
|
SECONDARY outcome
Timeframe: Time from first treatment with the study drug to the earliest of either disease progression or death from any cause, assessed up to 2 yearsThe Kaplan-Meier method will be used to evaluate time to event endpoints. Median PFS will be reported with a 95% confidence interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsWill be measured by genomic alterations in HR components at baseline and deoxyribonucleic acid (DNA) repair protein RAD51 homolog (RAD51) foci formation. The two integrated assays are genomics for alterations in HR genes and RAD51 foci formation. Both of these assays report binary results. The rate of response will be compared between binary variables using the Fisher's exact test. The log-rank test will be used to compare PFS between binary variables. Additional results from whole exome sequencing and ribonucleic acid sequencing (RNAseq) analysis on study samples will be reported in a descriptive fashion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsWill be assessed by immunohistochemistry (ICH). Macro ribonucleic acid (mRNA) expression may also be performed. Expression are reported as a continuous variable. Logistic regression will be used to estimate the odds of response for every unit increase in protein expression. Cox-regression will be used to evaluate the association between PFS and protein expression. Graphical displays such as box plots and Kaplan-Meier plots will be used to visualize the data. Evaluate for any association between presence of HR deficiency and increased clinical benefit from study treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsWill be assessed by ICH. mRNA expression may also be performed. Expression are reported as a continuous variable. Logistic regression will be used to estimate the odds of response for every unit increase in protein expression. Cox-regression will be used to evaluate the association between PFS and protein expression. Graphical displays such as box plots and Kaplan-Meier plots will be used to visualize the data. Evaluate for any association between MGMT expression and increased clinical benefit from the study treatment.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Olaparib, Temozolomide)
Serious events: 19 serious events
Other events: 22 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Treatment (Olaparib, Temozolomide)
n=22 participants at risk
Temozolomide: Given PO
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Renal and urinary disorders
Acute kidney injury
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Immune system disorders
Allergic reaction
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Cardiac disorders
Atrial fibrillation
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Gastrointestinal disorders
Diarrhea
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Vascular disorders
Hematoma
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Renal and urinary disorders
Hematuria
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Vascular disorders
Hypotension
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Investigations
Lymphocyte count decreased
|
9.1%
2/22 • Number of events 4 • 34 months
|
|
Investigations
Neutrophil count decreased
|
72.7%
16/22 • Number of events 28 • 34 months
|
|
Investigations
Platelet count decreased
|
31.8%
7/22 • Number of events 12 • 34 months
|
|
Cardiac disorders
Sinus tachycardia
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Investigations
White blood cell decreased
|
22.7%
5/22 • Number of events 9 • 34 months
|
Other adverse events
| Measure |
Treatment (Olaparib, Temozolomide)
n=22 participants at risk
Temozolomide: Given PO
|
|---|---|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.6%
3/22 • Number of events 7 • 34 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
9.1%
2/22 • Number of events 5 • 34 months
|
|
Investigations
INR increased
|
9.1%
2/22 • Number of events 13 • 34 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Psychiatric disorders
Insomnia
|
18.2%
4/22 • Number of events 49 • 34 months
|
|
Eye disorders
L eye irritation
|
4.5%
1/22 • Number of events 14 • 34 months
|
|
Investigations
Lymphocyte count decreased
|
31.8%
7/22 • Number of events 44 • 34 months
|
|
General disorders
Malaise
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Nervous system disorders
Memory impairment
|
4.5%
1/22 • Number of events 16 • 34 months
|
|
Gastrointestinal disorders
Mucositis oral
|
4.5%
1/22 • Number of events 13 • 34 months
|
|
Nervous system disorders
Muscle weakness left-sided
|
4.5%
1/22 • Number of events 9 • 34 months
|
|
Nervous system disorders
Muscle weakness right-sided
|
4.5%
1/22 • Number of events 9 • 34 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
4.5%
1/22 • Number of events 4 • 34 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.5%
1/22 • Number of events 16 • 34 months
|
|
Infections and infestations
Nail infection
|
4.5%
1/22 • Number of events 2 • 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.1%
2/22 • Number of events 10 • 34 months
|
|
Gastrointestinal disorders
Nausea
|
54.5%
12/22 • Number of events 121 • 34 months
|
|
Investigations
Neutrophil count decreased
|
81.8%
18/22 • Number of events 166 • 34 months
|
|
Gastrointestinal disorders
Oral hemorrhage
|
9.1%
2/22 • Number of events 3 • 34 months
|
|
Gastrointestinal disorders
Oral pain
|
18.2%
4/22 • Number of events 25 • 34 months
|
|
General disorders
Pain
|
18.2%
4/22 • Number of events 27 • 34 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
22.7%
5/22 • Number of events 22 • 34 months
|
|
Nervous system disorders
Paresthesia
|
9.1%
2/22 • Number of events 32 • 34 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
4.5%
1/22 • Number of events 9 • 34 months
|
|
Gastrointestinal disorders
Periodontal disease
|
4.5%
1/22 • Number of events 10 • 34 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.5%
1/22 • Number of events 5 • 34 months
|
|
Investigations
Platelet count decreased
|
86.4%
19/22 • Number of events 185 • 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.5%
1/22 • Number of events 2 • 34 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
18.2%
4/22 • Number of events 13 • 34 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
9.1%
2/22 • Number of events 4 • 34 months
|
|
Cardiac disorders
Sinus bradycardia
|
4.5%
1/22 • Number of events 3 • 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
4.5%
1/22 • Number of events 18 • 34 months
|
|
Cardiac disorders
Sinus tachycardia
|
13.6%
3/22 • Number of events 9 • 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
9.1%
2/22 • Number of events 2 • 34 months
|
|
Gastrointestinal disorders
Stomach Gas
|
4.5%
1/22 • Number of events 2 • 34 months
|
|
Gastrointestinal disorders
Stomach pain
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Ear and labyrinth disorders
Tinnitus
|
4.5%
1/22 • Number of events 5 • 34 months
|
|
Gastrointestinal disorders
Toothache
|
4.5%
1/22 • Number of events 2 • 34 months
|
|
Infections and infestations
Upper respiratory infection
|
9.1%
2/22 • Number of events 3 • 34 months
|
|
Infections and infestations
Urinary tract infection
|
9.1%
2/22 • Number of events 3 • 34 months
|
|
Renal and urinary disorders
Urinary urgency
|
4.5%
1/22 • Number of events 2 • 34 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Reproductive system and breast disorders
Vaginal discharge
|
4.5%
1/22 • Number of events 3 • 34 months
|
|
Infections and infestations
Vaginal infection
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Gastrointestinal disorders
Vomiting
|
31.8%
7/22 • Number of events 22 • 34 months
|
|
Investigations
Weight gain
|
13.6%
3/22 • Number of events 26 • 34 months
|
|
Investigations
Weight loss
|
9.1%
2/22 • Number of events 13 • 34 months
|
|
Investigations
White blood cell decreased
|
77.3%
17/22 • Number of events 190 • 34 months
|
|
Skin and subcutaneous tissue disorders
nail ridges peeling
|
4.5%
1/22 • Number of events 11 • 34 months
|
|
General disorders
pinching pain near vagina (left side)
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Reproductive system and breast disorders
small warty lesion on left labia
|
4.5%
1/22 • Number of events 8 • 34 months
|
|
General disorders
Edema limbs
|
27.3%
6/22 • Number of events 38 • 34 months
|
|
General disorders
Fatigue
|
63.6%
14/22 • Number of events 160 • 34 months
|
|
General disorders
Fever
|
22.7%
5/22 • Number of events 7 • 34 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.5%
1/22 • Number of events 2 • 34 months
|
|
Gastrointestinal disorders
Flatulence
|
4.5%
1/22 • Number of events 3 • 34 months
|
|
General disorders
Flu like symptoms
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Vascular disorders
Flushing
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
General disorders
Fogginess feeling
|
4.5%
1/22 • Number of events 2 • 34 months
|
|
Investigations
GGT increased
|
9.1%
2/22 • Number of events 10 • 34 months
|
|
General disorders
Gait disturbance
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
18.2%
4/22 • Number of events 48 • 34 months
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
4.5%
1/22 • Number of events 11 • 34 months
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Nervous system disorders
Headache
|
22.7%
5/22 • Number of events 37 • 34 months
|
|
Blood and lymphatic system disorders
Hemoglobin decrease
|
4.5%
1/22 • Number of events 2 • 34 months
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Infections and infestations
Herpes simplex reactivation
|
9.1%
2/22 • Number of events 2 • 34 months
|
|
Vascular disorders
Hot flashes
|
18.2%
4/22 • Number of events 15 • 34 months
|
|
Renal and urinary disorders
Hydronephrosis
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.5%
1/22 • Number of events 4 • 34 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
54.5%
12/22 • Number of events 55 • 34 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.5%
1/22 • Number of events 2 • 34 months
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
4.5%
1/22 • Number of events 5 • 34 months
|
|
Vascular disorders
Hypertension
|
27.3%
6/22 • Number of events 22 • 34 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
4.5%
1/22 • Number of events 15 • 34 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
13.6%
3/22 • Number of events 9 • 34 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
9.1%
2/22 • Number of events 5 • 34 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
18.2%
4/22 • Number of events 7 • 34 months
|
|
Gastrointestinal disorders
Abdominal pain
|
27.3%
6/22 • Number of events 26 • 34 months
|
|
Gastrointestinal disorders
Abdominal tenderness near umbilicus
|
4.5%
1/22 • Number of events 4 • 34 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.5%
1/22 • Number of events 8 • 34 months
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
2/22 • Number of events 7 • 34 months
|
|
Investigations
Alkaline phosphatase increased
|
22.7%
5/22 • Number of events 24 • 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.5%
1/22 • Number of events 17 • 34 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.5%
1/22 • Number of events 21 • 34 months
|
|
Gastrointestinal disorders
Anal fissure
|
4.5%
1/22 • Number of events 18 • 34 months
|
|
Blood and lymphatic system disorders
Anemia
|
72.7%
16/22 • Number of events 188 • 34 months
|
|
Metabolism and nutrition disorders
Anorexia
|
27.3%
6/22 • Number of events 22 • 34 months
|
|
Psychiatric disorders
Anxiety
|
4.5%
1/22 • Number of events 21 • 34 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
2/22 • Number of events 36 • 34 months
|
|
Investigations
Aspartate aminotransferase increased
|
9.1%
2/22 • Number of events 5 • 34 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.7%
5/22 • Number of events 45 • 34 months
|
|
Eye disorders
Blepharospasm (left eye)
|
4.5%
1/22 • Number of events 4 • 34 months
|
|
Investigations
Blood bicarbonate decreased
|
4.5%
1/22 • Number of events 2 • 34 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
13.6%
3/22 • Number of events 16 • 34 months
|
|
Eye disorders
Blurred vision
|
4.5%
1/22 • Number of events 14 • 34 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.5%
1/22 • Number of events 19 • 34 months
|
|
Reproductive system and breast disorders
Breast pain
|
4.5%
1/22 • Number of events 2 • 34 months
|
|
Infections and infestations
COVID-19
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Chest congestion
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
General disorders
Chills
|
9.1%
2/22 • Number of events 2 • 34 months
|
|
General disorders
Cold flashes
|
4.5%
1/22 • Number of events 2 • 34 months
|
|
General disorders
Cold flashes, intermittent
|
4.5%
1/22 • Number of events 11 • 34 months
|
|
Gastrointestinal disorders
Colitis
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Psychiatric disorders
Confusion
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Gastrointestinal disorders
Constipation
|
40.9%
9/22 • Number of events 61 • 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
4/22 • Number of events 7 • 34 months
|
|
Investigations
Creatinine increased
|
18.2%
4/22 • Number of events 7 • 34 months
|
|
Metabolism and nutrition disorders
Dehydration
|
4.5%
1/22 • Number of events 1 • 34 months
|
|
Psychiatric disorders
Depression
|
9.1%
2/22 • Number of events 4 • 34 months
|
|
Gastrointestinal disorders
Diarrhea
|
40.9%
9/22 • Number of events 42 • 34 months
|
|
Nervous system disorders
Dizziness
|
22.7%
5/22 • Number of events 31 • 34 months
|
|
Gastrointestinal disorders
Dry mouth
|
9.1%
2/22 • Number of events 32 • 34 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
18.2%
4/22 • Number of events 26 • 34 months
|
|
Nervous system disorders
Dysgeusia
|
13.6%
3/22 • Number of events 17 • 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.7%
5/22 • Number of events 36 • 34 months
|
|
Renal and urinary disorders
Dysuria
|
4.5%
1/22 • Number of events 3 • 34 months
|
|
General disorders
Edema face
|
4.5%
1/22 • Number of events 1 • 34 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60