Trial Outcomes & Findings for A Trial of Androgen Deprivation, Docetaxel, and Enzalutamide for Metastatic Prostate Cancer (NCT NCT03246347)

Last Updated: 2026-01-23

Results Overview

The 52-week PSA CR rate was defined as the proportion of participants achieving PSA complete response (CR) at 52-weeks (+/- 1 week) from date of enrollment (i.e., initiation of both enzalutamide and docetaxel) of all evaluable participants. PSA CR was defined as PSA level less than 0.2 ng/ml for two consecutive measurements at least three weeks apart (date of initial PSA level 0.2 ng/ml was acknowledged as date of response). In subjects with missed PSA assessments at 52 (+/- 1) weeks, (a) if a confirmed CR was achieved and at least one PSA assessment occurred beyond the 52-week window showed serologic complete response (providing the subject did not earlier experience confirmed progressive disease), the subject achieved 52-week PSA Complete Response and (b) if confirmed CR was achieved before the 52-week window and the first assessment after the 52-week window was not a CR, the subject did not achieve a 52-week PSA Complete Response.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

52 weeks

Results posted on

2026-01-23

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm Docetaxel + Enzalutamide + Androgen Deprivation Therapy ADT+Docetaxel+Enzalutamide: combination therapy as listed above
Overall Study STARTED	40
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm Docetaxel + Enzalutamide + Androgen Deprivation Therapy ADT+Docetaxel+Enzalutamide: combination therapy as listed above
Overall Study On Study	23

Baseline Characteristics

A Trial of Androgen Deprivation, Docetaxel, and Enzalutamide for Metastatic Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=40 Participants Docetaxel + Enzalutamide + Androgen Deprivation Therapy ADT+Docetaxel+Enzalutamide: combination therapy as listed above
Age, Categorical <=18 years	0 Participants n=270 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=270 Participants
Age, Categorical >=65 years	15 Participants n=270 Participants
Age, Continuous	64.95 years n=270 Participants
Sex: Female, Male Female	0 Participants n=270 Participants
Sex: Female, Male Male	40 Participants n=270 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=270 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=270 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=270 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=270 Participants
Race (NIH/OMB) Asian	0 Participants n=270 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=270 Participants
Race (NIH/OMB) Black or African American	14 Participants n=270 Participants
Race (NIH/OMB) White	26 Participants n=270 Participants
Race (NIH/OMB) More than one race	0 Participants n=270 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=270 Participants
Region of Enrollment United States	40 participants n=270 Participants
Disease volume at enrollment Low volume	10 Participants n=270 Participants
Disease volume at enrollment High volume	30 Participants n=270 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: The evaluable population for the primary analysis included subjects who began study treatment and did not discontinue enzalutamide prior to the development of castrate resistance for reasons other than can be attributed to study treatment. Four enrolled subjects were not evaluable for the analysis of the primary objective for reasons including consent withdrawal and noncompliance.

Outcome measures

Outcome measures
Measure	Single Arm n=36 Participants Docetaxel + Enzalutamide + Androgen Deprivation Therapy ADT+Docetaxel+Enzalutamide: combination therapy as listed above
52-week PSA Complete Response (CR) Rate	22 Participants

Adverse Events

Single Arm

Serious events: 14 serious events

Other events: 40 other events

Deaths: 13 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm n=40 participants at risk Docetaxel + Enzalutamide + Androgen Deprivation Therapy ADT+Docetaxel+Enzalutamide: combination therapy as listed above
Renal and urinary disorders ACUTE KIDNEY INJURY	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Cardiac disorders ATRIAL FLUTTER	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Musculoskeletal and connective tissue disorders BACK PAIN	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Cardiac disorders CARDIAC DISORDERS - OTHER, ICD Read Malfunction	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Gastrointestinal disorders COLITIS	2.5% 1/40 • Number of events 2 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Psychiatric disorders CONFUSION	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Metabolism and nutrition disorders DEHYDRATION	2.5% 1/40 • Number of events 2 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Gastrointestinal disorders DYSPHAGIA	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Respiratory, thoracic and mediastinal disorders DYSPNEA	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Nervous system disorders ENCEPHALOPATHY	5.0% 2/40 • Number of events 2 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Infections and infestations ESOPHAGEAL INFECTION	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Injury, poisoning and procedural complications FALL	5.0% 2/40 • Number of events 2 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	5.0% 2/40 • Number of events 2 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
General disorders FEVER	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Gastrointestinal disorders GASTROINTESTINAL DISORDERS - OTHER, Pneumoperitoneum	5.0% 2/40 • Number of events 2 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Musculoskeletal and connective tissue disorders GENERALIZED MUSCLE WEAKNESS	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Injury, poisoning and procedural complications HIP FRACTURE	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Metabolism and nutrition disorders HYPERGLYCEMIA	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Metabolism and nutrition disorders HYPOGLYCEMIA	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Infections and infestations INFECTIONS AND INFESTATIONS - OTHER, Bacteremia	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Injury, poisoning and procedural complications INJURY, POISONING AND PROCEDURE COMPLICATIONS - OTHER, MVA	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Infections and infestations KIDNEY INFECTION	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Infections and infestations LUNG INFECTION	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
General disorders MULTI-ORGAN FAILURE	2.5% 1/40 • Number of events 2 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Musculoskeletal and connective tissue disorders MUSCLE WEAKNESS RIGHT-SIDED	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED - OTHER, Urothelial Carcinoma	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Investigations NEUTROPHILL COUNT DECREASED	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
General disorders NON-CARDIAC CHEST PAIN	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Infections and infestations SEPSIS	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Nervous system disorders STROKE	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Infections and infestations URETHRAL INFECTION	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Infections and infestations URINARY TRACT INFECTION	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Renal and urinary disorders URINARY TRACT OBSTRUCTION	2.5% 1/40 • Number of events 2 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Investigations WHITE BLOOD CELL DECREASED	2.5% 1/40 • Number of events 1 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.

Other adverse events

Other adverse events
Measure	Single Arm n=40 participants at risk Docetaxel + Enzalutamide + Androgen Deprivation Therapy ADT+Docetaxel+Enzalutamide: combination therapy as listed above
Gastrointestinal disorders ABDOMINAL PAIN	15.0% 6/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Renal and urinary disorders ACUTE KIDNEY INJURY	10.0% 4/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Investigations ALKALINE PHOSPHATASE INCREASED	10.0% 4/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Respiratory, thoracic and mediastinal disorders ALLERGIC RHINITIS	12.5% 5/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Skin and subcutaneous tissue disorders ALOPECIA	40.0% 16/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Blood and lymphatic system disorders ANEMIA	10.0% 4/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Metabolism and nutrition disorders ANOREXIA	22.5% 9/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Musculoskeletal and connective tissue disorders ARTHRALGIA	32.5% 13/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Musculoskeletal and connective tissue disorders BACK PAIN	12.5% 5/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Musculoskeletal and connective tissue disorders BONE PAIN	10.0% 4/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Gastrointestinal disorders CONSTIPATION	10.0% 4/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Respiratory, thoracic and mediastinal disorders COUGH	22.5% 9/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Psychiatric disorders DEPRESSION	7.5% 3/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Gastrointestinal disorders DIARRHEA	32.5% 13/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Nervous system disorders DIZZINESS	20.0% 8/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Eye disorders DRY EYE	7.5% 3/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Skin and subcutaneous tissue disorders DRY SKIN	7.5% 3/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Nervous system disorders DYSGEUSIA	40.0% 16/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Gastrointestinal disorders DYSPHAGIA	7.5% 3/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Respiratory, thoracic and mediastinal disorders DYSPNEA	25.0% 10/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
General disorders EDEMA LIMBS	30.0% 12/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	7.5% 3/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Injury, poisoning and procedural complications FALL	12.5% 5/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
General disorders FATIGUE	80.0% 32/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
General disorders FLU LIKE SYMPTOMS	7.5% 3/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Gastrointestinal disorders GASTROESOPHAGEAL REFLUX DISEASE	7.5% 3/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Musculoskeletal and connective tissue disorders GENERALIZED MUSCLE WEAKNESS	20.0% 8/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Reproductive system and breast disorders GYNECOMASTIA	10.0% 4/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Nervous system disorders HEADACHE	17.5% 7/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Renal and urinary disorders HEMATURIA	10.0% 4/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Vascular disorders HOT FLASHES	32.5% 13/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Metabolism and nutrition disorders HYPERGLYCEMIA	10.0% 4/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Vascular disorders HYPERTENSION	12.5% 5/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Metabolism and nutrition disorders HYPOKALEMIA	7.5% 3/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Vascular disorders HYPOTENSION	12.5% 5/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Infections and infestations INFECTIONS AND INFESTATIONS - OTHER, SPECIFY: COVID-19	20.0% 8/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
General disorders INFUSION RELATED REACTION	7.5% 3/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Psychiatric disorders INSOMNIA	22.5% 9/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Infections and infestations LUNG INFECTION	10.0% 4/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Gastrointestinal disorders MUCOSITIS ORAL	7.5% 3/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Musculoskeletal and connective tissue disorders MUSCLE WEAKNESS LOWER LIMB	7.5% 3/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Musculoskeletal and connective tissue disorders MYALGIA	10.0% 4/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Skin and subcutaneous tissue disorders NAIL DISCOLORATION	27.5% 11/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Infections and infestations NAIL INFECTION	7.5% 3/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Skin and subcutaneous tissue disorders NAIL LOSS	15.0% 6/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	10.0% 4/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Gastrointestinal disorders NAUSEA	35.0% 14/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Nervous system disorders NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY: RESTLESS LEG SYNDROME	7.5% 3/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Investigations NEUTROPHIL COUNT DECREASED	15.0% 6/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
General disorders NON-CARDIAC CHEST PAIN	10.0% 4/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Gastrointestinal disorders ORAL PAIN	7.5% 3/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
General disorders PAIN	25.0% 10/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	20.0% 8/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Nervous system disorders PARESTHESIA	12.5% 5/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	45.0% 18/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Respiratory, thoracic and mediastinal disorders SORE THROAT	7.5% 3/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Gastrointestinal disorders TOOTHACHE	7.5% 3/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Infections and infestations UPPER RESPIRATORY INFECTION	12.5% 5/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Renal and urinary disorders URINARY FREQUENCY	15.0% 6/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Renal and urinary disorders URINARY RETENTION	7.5% 3/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Infections and infestations URINARY TRACT INFECTION	10.0% 4/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Ear and labyrinth disorders VERTIGO	7.5% 3/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Gastrointestinal disorders VOMITING	20.0% 8/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Eye disorders WATERING EYES	15.0% 6/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Investigations WEIGHT GAIN	20.0% 8/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Investigations WEIGHT LOSS	12.5% 5/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Investigations WHITE BLOOD CELL DECREASED	10.0% 4/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Gastrointestinal disorders DYSPEPSIA	7.5% 3/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	7.5% 3/40 • Adverse events are collected from initiation of study drugs to 30 days following cessation of study drugs. The maximum adverse event collection timeframe was 5.8 years. Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.

Additional Information

Danielle Boselli

Wake Forest

Phone: 2017903385

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place