Trial Outcomes & Findings for Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer (NCT NCT03289039)
NCT ID: NCT03289039
Last Updated: 2026-01-22
Results Overview
Progression-Free Survival (PFS) is defined as the time from randomization (or registration) to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Disease assessment were conducted at baseline and every two cycles after the first cycle.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Participants were followed for PFS up to 20.3 months from registration.
Results posted on
2026-01-22
Participant Flow
Participant milestones
| Measure |
Neratinib
* Neratinib will be administered orally once daily
* Neratinib is dosed at 240mg (six 40mg tablets)
Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)
|
Neratinib + Fulvestrant
* Neratinib will be administered orally once daily
* Neratinib is dosed at 240mg (six 40mg tablets)
* Fulvestrant will be administered intramuscular as an injection (shot) on day 1 and 15 of cycle 1, day 1 of cycle 2, and then on day 1 of each subsequent cycle.
* Fulvestrant is dosed as 250 mg/5mL (x2) for a total of 500 mg via intramuscular injection (two injections).
Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)
Fulvestrant: Fulvestrant, works in treating breast cancer that has spread to other parts of the body
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Neratinib
* Neratinib will be administered orally once daily
* Neratinib is dosed at 240mg (six 40mg tablets)
Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)
|
Neratinib + Fulvestrant
* Neratinib will be administered orally once daily
* Neratinib is dosed at 240mg (six 40mg tablets)
* Fulvestrant will be administered intramuscular as an injection (shot) on day 1 and 15 of cycle 1, day 1 of cycle 2, and then on day 1 of each subsequent cycle.
* Fulvestrant is dosed as 250 mg/5mL (x2) for a total of 500 mg via intramuscular injection (two injections).
Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)
Fulvestrant: Fulvestrant, works in treating breast cancer that has spread to other parts of the body
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Became ineligible prior to treatment start
|
0
|
1
|
|
Overall Study
progressed before treatment start
|
1
|
0
|
Baseline Characteristics
Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Neratinib
n=10 Participants
* Neratinib will be administered orally once daily
* Neratinib is dosed at 240mg (six 40mg tablets)
Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)
|
Neratinib + Fulvestrant
n=8 Participants
* Neratinib will be administered orally once daily
* Neratinib is dosed at 240mg (six 40mg tablets)
* Fulvestrant will be administered intramuscular as an injection (shot) on day 1 and 15 of cycle 1, day 1 of cycle 2, and then on day 1 of each subsequent cycle.
* Fulvestrant is dosed as 250 mg/5mL (x2) for a total of 500 mg via intramuscular injection (two injections).
Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)
Fulvestrant: Fulvestrant, works in treating breast cancer that has spread to other parts of the body
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
n=270 Participants
|
55.5 years
n=4 Participants
|
55 years
n=9 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=270 Participants
|
8 Participants
n=4 Participants
|
18 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=270 Participants
|
8 Participants
n=4 Participants
|
18 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=270 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
8 Participants
n=270 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=9 Participants
|
|
Prior use of Fulvestrant
Yes
|
3 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=9 Participants
|
|
Prior use of Fulvestrant
No
|
7 Participants
n=270 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=9 Participants
|
|
Prior lines of therapy
Less than or equal to 3 lines
|
1 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
|
Prior lines of therapy
Greater than 3 lines
|
9 Participants
n=270 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Participants were followed for PFS up to 20.3 months from registration.Population: Only treated participants
Progression-Free Survival (PFS) is defined as the time from randomization (or registration) to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Disease assessment were conducted at baseline and every two cycles after the first cycle.
Outcome measures
| Measure |
Neratinib
n=10 Participants
* Neratinib will be administered orally once daily
* Neratinib is dosed at 240mg (six 40mg tablets)
Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)
|
Neratinib + Fulvestrant
n=8 Participants
* Neratinib will be administered orally once daily
* Neratinib is dosed at 240mg (six 40mg tablets)
* Fulvestrant will be administered intramuscular as an injection (shot) on day 1 and 15 of cycle 1, day 1 of cycle 2, and then on day 1 of each subsequent cycle.
* Fulvestrant is dosed as 250 mg/5mL (x2) for a total of 500 mg via intramuscular injection (two injections).
Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)
Fulvestrant: Fulvestrant, works in treating breast cancer that has spread to other parts of the body
|
|---|---|---|
|
Progression Free Survival
Less than 4 prior lines of therapy; no prior use of fulvestrant
|
19.58 months
The sample size for this group is too small to have a valid interval.
|
1.74 months
The sample size for this group is too small to have a valid interval.
|
|
Progression Free Survival
More than 3 prior lines of therapy; no prior use of fulvestrant
|
1.81 months
Interval 1.81 to
The sample size for this group is too small to have a valid interval.
|
3.84 months
Interval 1.61 to
The sample size for this group is too small to have a valid interval.
|
|
Progression Free Survival
More than 3 prior lines of therapy; prior use of fulvestrant
|
6.42 months
Interval 5.55 to
The sample size for this group is too small to have a valid interval.
|
—
|
SECONDARY outcome
Timeframe: Participants were followed for up to 38.4 months (3 years and 2 months) from registration to removal from protocol therapy or death.Population: Only included the treated participants.
Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive. Participants will be evaluated every 6 months for survival until death. Participants removed from protocol therapy for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
Outcome measures
| Measure |
Neratinib
n=10 Participants
* Neratinib will be administered orally once daily
* Neratinib is dosed at 240mg (six 40mg tablets)
Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)
|
Neratinib + Fulvestrant
n=8 Participants
* Neratinib will be administered orally once daily
* Neratinib is dosed at 240mg (six 40mg tablets)
* Fulvestrant will be administered intramuscular as an injection (shot) on day 1 and 15 of cycle 1, day 1 of cycle 2, and then on day 1 of each subsequent cycle.
* Fulvestrant is dosed as 250 mg/5mL (x2) for a total of 500 mg via intramuscular injection (two injections).
Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)
Fulvestrant: Fulvestrant, works in treating breast cancer that has spread to other parts of the body
|
|---|---|---|
|
Overall Survival
Less than 4 prior lines of therapy; no prior fulvestrant use
|
NA months
Did not reach median survival.
|
12.22 months
Sample size too small to get a valid confidence interval.
|
|
Overall Survival
More than 3 prior lines of therapy; no prior fulvestrant use
|
20.17 months
Interval 12.91 to
Sample size too small to get a valid confidence interval.
|
19.91 months
Interval 13.63 to
Sample size too small to get a valid confidence interval.
|
|
Overall Survival
More than 3 prior lines of therapy; prior fulvestrant use
|
27.79 months
Sample size too small to get a valid confidence interval.
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Overall Response Rate(ORR) = (CR + PR)/sample size.
Outcome measures
| Measure |
Neratinib
n=10 Participants
* Neratinib will be administered orally once daily
* Neratinib is dosed at 240mg (six 40mg tablets)
Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)
|
Neratinib + Fulvestrant
n=8 Participants
* Neratinib will be administered orally once daily
* Neratinib is dosed at 240mg (six 40mg tablets)
* Fulvestrant will be administered intramuscular as an injection (shot) on day 1 and 15 of cycle 1, day 1 of cycle 2, and then on day 1 of each subsequent cycle.
* Fulvestrant is dosed as 250 mg/5mL (x2) for a total of 500 mg via intramuscular injection (two injections).
Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)
Fulvestrant: Fulvestrant, works in treating breast cancer that has spread to other parts of the body
|
|---|---|---|
|
Overall Response Rate
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 yearsThe duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, or death due to any cause. Participants without events reported are censored at the last disease evaluation).
Outcome measures
| Measure |
Neratinib
n=10 Participants
* Neratinib will be administered orally once daily
* Neratinib is dosed at 240mg (six 40mg tablets)
Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)
|
Neratinib + Fulvestrant
n=8 Participants
* Neratinib will be administered orally once daily
* Neratinib is dosed at 240mg (six 40mg tablets)
* Fulvestrant will be administered intramuscular as an injection (shot) on day 1 and 15 of cycle 1, day 1 of cycle 2, and then on day 1 of each subsequent cycle.
* Fulvestrant is dosed as 250 mg/5mL (x2) for a total of 500 mg via intramuscular injection (two injections).
Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)
Fulvestrant: Fulvestrant, works in treating breast cancer that has spread to other parts of the body
|
|---|---|---|
|
Duration Of Responses
|
NA months
No patient had a response.
|
6.7 months
There was only one patient who had a response. The duration of response is 6.7 months.
|
Adverse Events
Neratinib
Serious events: 4 serious events
Other events: 10 other events
Deaths: 6 deaths
Neratinib + Fulvestrant
Serious events: 2 serious events
Other events: 8 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Neratinib
n=10 participants at risk
* Neratinib will be administered orally once daily
* Neratinib is dosed at 240mg (six 40mg tablets)
Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)
|
Neratinib + Fulvestrant
n=8 participants at risk
* Neratinib will be administered orally once daily
* Neratinib is dosed at 240mg (six 40mg tablets)
* Fulvestrant will be administered intramuscular as an injection (shot) on day 1 and 15 of cycle 1, day 1 of cycle 2, and then on day 1 of each subsequent cycle.
* Fulvestrant is dosed as 250 mg/5mL (x2) for a total of 500 mg via intramuscular injection (two injections).
Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)
Fulvestrant: Fulvestrant, works in treating breast cancer that has spread to other parts of the body
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Infections and infestations
Skin infection
|
0.00%
0/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
General disorders
Fatigue
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
General disorders
Malaise
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Infections and infestations
Sepsis
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Investigations
CPK increased
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
2/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Psychiatric disorders
Confusion
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Renal and urinary disorders
Bladder perforation
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
Other adverse events
| Measure |
Neratinib
n=10 participants at risk
* Neratinib will be administered orally once daily
* Neratinib is dosed at 240mg (six 40mg tablets)
Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)
|
Neratinib + Fulvestrant
n=8 participants at risk
* Neratinib will be administered orally once daily
* Neratinib is dosed at 240mg (six 40mg tablets)
* Fulvestrant will be administered intramuscular as an injection (shot) on day 1 and 15 of cycle 1, day 1 of cycle 2, and then on day 1 of each subsequent cycle.
* Fulvestrant is dosed as 250 mg/5mL (x2) for a total of 500 mg via intramuscular injection (two injections).
Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)
Fulvestrant: Fulvestrant, works in treating breast cancer that has spread to other parts of the body
|
|---|---|---|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
2/10 • 38.4 months (3 years and 2 months)
|
25.0%
2/8 • 38.4 months (3 years and 2 months)
|
|
Gastrointestinal disorders
Constipation
|
70.0%
7/10 • 38.4 months (3 years and 2 months)
|
62.5%
5/8 • 38.4 months (3 years and 2 months)
|
|
Gastrointestinal disorders
Diarrhea
|
80.0%
8/10 • 38.4 months (3 years and 2 months)
|
62.5%
5/8 • 38.4 months (3 years and 2 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
20.0%
2/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Gastrointestinal disorders
Mucositis oral
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10 • 38.4 months (3 years and 2 months)
|
50.0%
4/8 • 38.4 months (3 years and 2 months)
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • 38.4 months (3 years and 2 months)
|
25.0%
2/8 • 38.4 months (3 years and 2 months)
|
|
General disorders
Edema limbs
|
0.00%
0/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
General disorders
Fatigue
|
60.0%
6/10 • 38.4 months (3 years and 2 months)
|
62.5%
5/8 • 38.4 months (3 years and 2 months)
|
|
General disorders
Fever
|
0.00%
0/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
General disorders
Pain
|
40.0%
4/10 • 38.4 months (3 years and 2 months)
|
50.0%
4/8 • 38.4 months (3 years and 2 months)
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Infections and infestations
Skin infection
|
0.00%
0/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
2/10 • 38.4 months (3 years and 2 months)
|
25.0%
2/8 • 38.4 months (3 years and 2 months)
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
2/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
5/10 • 38.4 months (3 years and 2 months)
|
25.0%
2/8 • 38.4 months (3 years and 2 months)
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
50.0%
4/8 • 38.4 months (3 years and 2 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
30.0%
3/10 • 38.4 months (3 years and 2 months)
|
37.5%
3/8 • 38.4 months (3 years and 2 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • 38.4 months (3 years and 2 months)
|
25.0%
2/8 • 38.4 months (3 years and 2 months)
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Nervous system disorders
Peripheral motor neuropathy
|
20.0%
2/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/10 • 38.4 months (3 years and 2 months)
|
25.0%
2/8 • 38.4 months (3 years and 2 months)
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
25.0%
2/8 • 38.4 months (3 years and 2 months)
|
|
Psychiatric disorders
Depression
|
20.0%
2/10 • 38.4 months (3 years and 2 months)
|
25.0%
2/8 • 38.4 months (3 years and 2 months)
|
|
Psychiatric disorders
Insomnia
|
20.0%
2/10 • 38.4 months (3 years and 2 months)
|
25.0%
2/8 • 38.4 months (3 years and 2 months)
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Skin and subcutaneous tissue disorders
Skin/subcutaneous tissue disorders; Other, specify
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Vascular disorders
Hot flashes
|
20.0%
2/10 • 38.4 months (3 years and 2 months)
|
12.5%
1/8 • 38.4 months (3 years and 2 months)
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
2/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Ear and labyrinth disorders
Hearing impaired
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Gastrointestinal disorders
Toothache
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
General disorders
Malaise
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
General disorders
Non-cardiac chest pain
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Infections and infestations
Bronchial infection
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Infections and infestations
Papulopustular rash
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Infections and infestations
Paronychia
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Investigations
Blood bilirubin increased
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Investigations
Investigations - Other, specify
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Investigations
Neutrophil count decreased
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Investigations
Platelet count decreased
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Investigations
Weight loss
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Investigations
White blood cell decreased
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
20.0%
2/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
20.0%
2/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Nervous system disorders
Lethargy
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Psychiatric disorders
Confusion
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
2/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
20.0%
2/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Vascular disorders
Hematoma
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • 38.4 months (3 years and 2 months)
|
0.00%
0/8 • 38.4 months (3 years and 2 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place