Trial Outcomes & Findings for Carboplatin, Gemcitabine Hydrochloride, and Berzosertib in Treating Patients With Recurrent and Metastatic Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (NCT NCT02627443)
NCT ID: NCT02627443
Last Updated: 2026-04-13
Results Overview
DLT will be defined as grade 4 absolute neutrophil count for ≥ 5 days, grade 4 anemia, platelet count \< 25,000, or other non-hematologic events ≥ grade 3 as per NCI Common Terminology Criteria for Adverse Events Version 4.0 (except fatigue, alopecia and anorexia). The MTD in this study will be defined as the highest safely tolerated dose, up to a maximum of dose level 4, where at most 1 out of six patients experience a DLT with the next higher dose having at least 2 DLTs in 3 or more patients.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
35 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2026-04-13
Participant Flow
Participant milestones
| Measure |
Dose Level 1
VX-970 90 mg/m2 IV over 60 min on day 2 and 9, gemcitabine 640 mg/m2 IV over 30 min on days 1 and 8, CARBOplatin AUC4 IV over 30 min on day 1
|
Dose Level 2
VX-970 90 mg/m2 IV over 60 min on day 2 and 9, gemcitabine 800 mg/m2 IV over 30 min on days 1 and 8, CARBOplatin AUC4 IV over 30 min on day 1
|
|---|---|---|
|
Safety/Lead-in Phase
STARTED
|
6
|
5
|
|
Safety/Lead-in Phase
COMPLETED
|
6
|
5
|
|
Safety/Lead-in Phase
NOT COMPLETED
|
0
|
0
|
|
Expansion Phase
STARTED
|
24
|
0
|
|
Expansion Phase
COMPLETED
|
22
|
0
|
|
Expansion Phase
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Dose Level 1
VX-970 90 mg/m2 IV over 60 min on day 2 and 9, gemcitabine 640 mg/m2 IV over 30 min on days 1 and 8, CARBOplatin AUC4 IV over 30 min on day 1
|
Dose Level 2
VX-970 90 mg/m2 IV over 60 min on day 2 and 9, gemcitabine 800 mg/m2 IV over 30 min on days 1 and 8, CARBOplatin AUC4 IV over 30 min on day 1
|
|---|---|---|
|
Expansion Phase
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Carboplatin, Gemcitabine Hydrochloride, and Berzosertib in Treating Patients With Recurrent and Metastatic Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=30 Participants
VX-970 90 mg/m2 IV over 60 min on day 2 and 9, gemcitabine 640 mg/m2 IV over 30 min on days 1 and 8, CARBOplatin AUC4 IV over 30 min on day 1
|
Dose Level 2
n=5 Participants
VX-970 90 mg/m2 IV over 60 min on day 2 and 9, gemcitabine 800 mg/m2 IV over 30 min on days 1 and 8, CARBOplatin AUC4 IV over 30 min on day 1
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.233 years
STANDARD_DEVIATION 9.302 • n=193 Participants
|
55.400 years
STANDARD_DEVIATION 12.896 • n=193 Participants
|
62.114 years
STANDARD_DEVIATION 10.055 • n=386 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=193 Participants
|
5 Participants
n=193 Participants
|
35 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
3 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=193 Participants
|
4 Participants
n=193 Participants
|
32 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=193 Participants
|
4 Participants
n=193 Participants
|
30 Participants
n=386 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
|
Primary Site
Fallopian tube
|
3 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
4 Participants
n=386 Participants
|
|
Primary Site
Lymph node
|
1 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
|
Primary Site
Ovary
|
23 Participants
n=193 Participants
|
4 Participants
n=193 Participants
|
27 Participants
n=386 Participants
|
|
Primary Site
Pelvis
|
1 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
|
Primary Site
Peritoneum
|
2 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
|
ECOG
0
|
17 Participants
n=193 Participants
|
5 Participants
n=193 Participants
|
22 Participants
n=386 Participants
|
|
ECOG
1
|
13 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
13 Participants
n=386 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysDLT will be defined as grade 4 absolute neutrophil count for ≥ 5 days, grade 4 anemia, platelet count \< 25,000, or other non-hematologic events ≥ grade 3 as per NCI Common Terminology Criteria for Adverse Events Version 4.0 (except fatigue, alopecia and anorexia). The MTD in this study will be defined as the highest safely tolerated dose, up to a maximum of dose level 4, where at most 1 out of six patients experience a DLT with the next higher dose having at least 2 DLTs in 3 or more patients.
Outcome measures
| Measure |
Dose Level 1
n=6 Participants
VX-970 90 mg/m2 IV over 60 min on day 2 and 9, gemcitabine 640 mg/m2 IV over 30 min on days 1 and 8, CARBOplatin AUC4 IV over 30 min on day 1
|
Dose Level 2
n=5 Participants
VX-970 90 mg/m2 IV over 60 min on day 2 and 9, gemcitabine 800 mg/m2 IV over 30 min on days 1 and 8, CARBOplatin AUC4 IV over 30 min on day 1
|
|---|---|---|
|
Dost Limiting Toxicity (DLT) (Phase I Dose Escalation)
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsThe maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Outcome measures
| Measure |
Dose Level 1
n=28 Participants
VX-970 90 mg/m2 IV over 60 min on day 2 and 9, gemcitabine 640 mg/m2 IV over 30 min on days 1 and 8, CARBOplatin AUC4 IV over 30 min on day 1
|
Dose Level 2
n=5 Participants
VX-970 90 mg/m2 IV over 60 min on day 2 and 9, gemcitabine 800 mg/m2 IV over 30 min on days 1 and 8, CARBOplatin AUC4 IV over 30 min on day 1
|
|---|---|---|
|
Incidence of Adverse Events
Grade 4+ Non-Heme Adverse Event
|
1 Participants
|
0 Participants
|
|
Incidence of Adverse Events
Grade 3+ Adverse Event
|
28 Participants
|
5 Participants
|
|
Incidence of Adverse Events
Grade 4+ Adverse Event
|
18 Participants
|
4 Participants
|
|
Incidence of Adverse Events
Grade 5 Adverse Event
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events
Grade 3+ Heme Adverse Event
|
27 Participants
|
5 Participants
|
|
Incidence of Adverse Events
Grade 4+ Heme Adverse Event
|
18 Participants
|
4 Participants
|
|
Incidence of Adverse Events
Grade 5 Heme Adverse Event
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events
Grade 3+ Non-Heme Adverse Event
|
17 Participants
|
2 Participants
|
|
Incidence of Adverse Events
Grade 5 Non-Heme Adverse Event
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsWill be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From study entry to death from any cause, assessed up to 3 yearsOS will be estimated using the Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first documented date of confirmed response (complete response [CR] or partial response [PR]), to the date at which progression is first documented, up to 3 yearsThe duration of confirmed responses will be assessed using the Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From registration to the first of either disease progression or death from any cause, up to 3 yearsDisease progression will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. PFS will be estimated using the Kaplan-Meier method.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to 3 yearsSemi-quantitative data will be used to compare the data between the treatment arms using boxplots and descriptive statistics.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsStatistical and graphical techniques will be used to explore these relationships. For time-to-event endpoints, we will use Cox proportional hazards models, and for response data we will use Logistic regression models. In addition, we will use Fisher's exact tests to test the association between categorical marker data and response.
Outcome measures
Outcome data not reported
Adverse Events
Dose Level 1
Serious events: 11 serious events
Other events: 28 other events
Deaths: 21 deaths
Dose Level 2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Dose Level 1
n=28 participants at risk
VX-970 90 mg/m2 IV over 60 min on day 2 and 9, gemcitabine 640 mg/m2 IV over 30 min on days 1 and 8, CARBOplatin AUC4 IV over 30 min on day 1
|
Dose Level 2
n=5 participants at risk
VX-970 90 mg/m2 IV over 60 min on day 2 and 9, gemcitabine 800 mg/m2 IV over 30 min on days 1 and 8, CARBOplatin AUC4 IV over 30 min on day 1
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
7.1%
2/28 • Number of events 2 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
17.9%
5/28 • Number of events 5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Gastrointestinal disorders
Colonic obstruction
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
General disorders
Fatigue
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
General disorders
Fever
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Infections and infestations
Bronchial infection
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Infections and infestations
Kidney infection
|
3.6%
1/28 • Number of events 2 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Investigations
Lymphocyte count decreased
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Investigations
Neutrophil count decreased
|
10.7%
3/28 • Number of events 4 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Investigations
Platelet count decreased
|
28.6%
8/28 • Number of events 10 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Investigations
White blood cell decreased
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Psychiatric disorders
Anxiety
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Psychiatric disorders
Depression
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Psychiatric disorders
Suicidal ideation
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.6%
1/28 • Number of events 2 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
Other adverse events
| Measure |
Dose Level 1
n=28 participants at risk
VX-970 90 mg/m2 IV over 60 min on day 2 and 9, gemcitabine 640 mg/m2 IV over 30 min on days 1 and 8, CARBOplatin AUC4 IV over 30 min on day 1
|
Dose Level 2
n=5 participants at risk
VX-970 90 mg/m2 IV over 60 min on day 2 and 9, gemcitabine 800 mg/m2 IV over 30 min on days 1 and 8, CARBOplatin AUC4 IV over 30 min on day 1
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
96.4%
27/28 • Number of events 222 • Up to 3 years
|
80.0%
4/5 • Number of events 36 • Up to 3 years
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
7.1%
2/28 • Number of events 5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
7.1%
2/28 • Number of events 3 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Oth spec
|
0.00%
0/28 • Up to 3 years
|
20.0%
1/5 • Number of events 2 • Up to 3 years
|
|
Ear and labyrinth disorders
Ear pain
|
7.1%
2/28 • Number of events 3 • Up to 3 years
|
20.0%
1/5 • Number of events 6 • Up to 3 years
|
|
Eye disorders
Blurred vision
|
10.7%
3/28 • Number of events 16 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Eye disorders
Dry eye
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/28 • Up to 3 years
|
20.0%
1/5 • Number of events 3 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
21.4%
6/28 • Number of events 15 • Up to 3 years
|
40.0%
2/5 • Number of events 2 • Up to 3 years
|
|
Gastrointestinal disorders
Bloating
|
14.3%
4/28 • Number of events 4 • Up to 3 years
|
20.0%
1/5 • Number of events 3 • Up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
50.0%
14/28 • Number of events 58 • Up to 3 years
|
60.0%
3/5 • Number of events 14 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
7/28 • Number of events 29 • Up to 3 years
|
40.0%
2/5 • Number of events 4 • Up to 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
10.7%
3/28 • Number of events 6 • Up to 3 years
|
40.0%
2/5 • Number of events 7 • Up to 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
14.3%
4/28 • Number of events 6 • Up to 3 years
|
40.0%
2/5 • Number of events 4 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
50.0%
14/28 • Number of events 56 • Up to 3 years
|
40.0%
2/5 • Number of events 4 • Up to 3 years
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/28 • Up to 3 years
|
20.0%
1/5 • Number of events 3 • Up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
21.4%
6/28 • Number of events 13 • Up to 3 years
|
60.0%
3/5 • Number of events 5 • Up to 3 years
|
|
General disorders
Edema face
|
3.6%
1/28 • Number of events 2 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
General disorders
Edema limbs
|
14.3%
4/28 • Number of events 15 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
General disorders
Facial pain
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
General disorders
Fatigue
|
82.1%
23/28 • Number of events 137 • Up to 3 years
|
60.0%
3/5 • Number of events 14 • Up to 3 years
|
|
General disorders
Fever
|
17.9%
5/28 • Number of events 10 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
3.6%
1/28 • Number of events 2 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
General disorders
Localized edema
|
3.6%
1/28 • Number of events 4 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
General disorders
Malaise
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
General disorders
Pain
|
10.7%
3/28 • Number of events 5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/28 • Up to 3 years
|
20.0%
1/5 • Number of events 4 • Up to 3 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Infections and infestations
Lip infection
|
0.00%
0/28 • Up to 3 years
|
20.0%
1/5 • Number of events 2 • Up to 3 years
|
|
Infections and infestations
Lung infection
|
7.1%
2/28 • Number of events 3 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Infections and infestations
Pharyngitis
|
3.6%
1/28 • Number of events 2 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Infections and infestations
Sepsis
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Infections and infestations
Skin infection
|
7.1%
2/28 • Number of events 3 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Infections and infestations
Upper respiratory infection
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Infections and infestations
Urinary tract infection
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
3.6%
1/28 • Number of events 3 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Bruising
|
25.0%
7/28 • Number of events 22 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
7.1%
2/28 • Number of events 3 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.1%
2/28 • Number of events 2 • Up to 3 years
|
20.0%
1/5 • Number of events 3 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Wound complication
|
3.6%
1/28 • Number of events 5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Investigations
Alanine aminotransferase increased
|
28.6%
8/28 • Number of events 35 • Up to 3 years
|
60.0%
3/5 • Number of events 11 • Up to 3 years
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
7/28 • Number of events 19 • Up to 3 years
|
20.0%
1/5 • Number of events 8 • Up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
17.9%
5/28 • Number of events 20 • Up to 3 years
|
40.0%
2/5 • Number of events 4 • Up to 3 years
|
|
Investigations
Creatinine increased
|
17.9%
5/28 • Number of events 12 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Investigations
Investigations - Other, specify
|
21.4%
6/28 • Number of events 21 • Up to 3 years
|
40.0%
2/5 • Number of events 15 • Up to 3 years
|
|
Investigations
Lymphocyte count decreased
|
39.3%
11/28 • Number of events 48 • Up to 3 years
|
60.0%
3/5 • Number of events 5 • Up to 3 years
|
|
Investigations
Neutrophil count decreased
|
96.4%
27/28 • Number of events 140 • Up to 3 years
|
100.0%
5/5 • Number of events 20 • Up to 3 years
|
|
Investigations
Platelet count decreased
|
67.9%
19/28 • Number of events 75 • Up to 3 years
|
40.0%
2/5 • Number of events 2 • Up to 3 years
|
|
Investigations
Weight gain
|
3.6%
1/28 • Number of events 2 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Investigations
Weight loss
|
7.1%
2/28 • Number of events 4 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Investigations
White blood cell decreased
|
64.3%
18/28 • Number of events 113 • Up to 3 years
|
80.0%
4/5 • Number of events 10 • Up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
17.9%
5/28 • Number of events 17 • Up to 3 years
|
40.0%
2/5 • Number of events 6 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
32.1%
9/28 • Number of events 27 • Up to 3 years
|
40.0%
2/5 • Number of events 9 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.6%
1/28 • Number of events 3 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.1%
2/28 • Number of events 2 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
17.9%
5/28 • Number of events 7 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.1%
2/28 • Number of events 3 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.7%
3/28 • Number of events 4 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.6%
1/28 • Number of events 2 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
2/28 • Number of events 15 • Up to 3 years
|
40.0%
2/5 • Number of events 7 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.9%
5/28 • Number of events 15 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
21.4%
6/28 • Number of events 12 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.1%
2/28 • Number of events 5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
10.7%
3/28 • Number of events 22 • Up to 3 years
|
20.0%
1/5 • Number of events 6 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.7%
3/28 • Number of events 13 • Up to 3 years
|
20.0%
1/5 • Number of events 3 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.6%
1/28 • Number of events 2 • Up to 3 years
|
20.0%
1/5 • Number of events 4 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
2/28 • Number of events 4 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Nervous system disorders
Dizziness
|
21.4%
6/28 • Number of events 15 • Up to 3 years
|
60.0%
3/5 • Number of events 4 • Up to 3 years
|
|
Nervous system disorders
Dysgeusia
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Nervous system disorders
Headache
|
21.4%
6/28 • Number of events 19 • Up to 3 years
|
60.0%
3/5 • Number of events 5 • Up to 3 years
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
3.6%
1/28 • Number of events 2 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.7%
3/28 • Number of events 12 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Nervous system disorders
Syncope
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Nervous system disorders
Tremor
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Psychiatric disorders
Anxiety
|
3.6%
1/28 • Number of events 2 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Psychiatric disorders
Depression
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Psychiatric disorders
Insomnia
|
10.7%
3/28 • Number of events 9 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Psychiatric disorders
Restlessness
|
3.6%
1/28 • Number of events 4 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Renal and urinary disorders
Urinary frequency
|
3.6%
1/28 • Number of events 9 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Renal and urinary disorders
Urinary tract pain
|
3.6%
1/28 • Number of events 3 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/28 • Up to 3 years
|
20.0%
1/5 • Number of events 6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/28 • Up to 3 years
|
20.0%
1/5 • Number of events 2 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
4/28 • Number of events 13 • Up to 3 years
|
20.0%
1/5 • Number of events 4 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.6%
8/28 • Number of events 14 • Up to 3 years
|
40.0%
2/5 • Number of events 10 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
4/28 • Number of events 12 • Up to 3 years
|
20.0%
1/5 • Number of events 2 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
2/28 • Number of events 2 • Up to 3 years
|
40.0%
2/5 • Number of events 6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/28 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
3.6%
1/28 • Number of events 2 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.7%
3/28 • Number of events 5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
39.3%
11/28 • Number of events 44 • Up to 3 years
|
40.0%
2/5 • Number of events 3 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
2/28 • Number of events 5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.1%
2/28 • Number of events 4 • Up to 3 years
|
20.0%
1/5 • Number of events 4 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
4/28 • Number of events 16 • Up to 3 years
|
40.0%
2/5 • Number of events 2 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/28 • Up to 3 years
|
20.0%
1/5 • Number of events 4 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
3.6%
1/28 • Number of events 9 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Vascular disorders
Hematoma
|
3.6%
1/28 • Number of events 3 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Vascular disorders
Hot flashes
|
3.6%
1/28 • Number of events 6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Vascular disorders
Hypertension
|
35.7%
10/28 • Number of events 32 • Up to 3 years
|
20.0%
1/5 • Number of events 2 • Up to 3 years
|
|
Vascular disorders
Hypotension
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Vascular disorders
Phlebitis
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Vascular disorders
Superficial thrombophlebitis
|
3.6%
1/28 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Vascular disorders
Thromboembolic event
|
10.7%
3/28 • Number of events 7 • Up to 3 years
|
20.0%
1/5 • Number of events 4 • Up to 3 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
3.6%
1/28 • Number of events 2 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60