Trial Outcomes & Findings for Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment (NCT NCT05631795)
NCT ID: NCT05631795
Last Updated: 2026-07-09
Results Overview
Treatment-Emergent Adverse Events (TEAEs) were defined as the adverse events that occurred, or worsened, during the treatment period (i.e. from the first dose of treatment up to 30 days after the last dose of study drug).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 7 months
Results posted on
2026-07-09
Participant Flow
This study was conducted at 16 centers in India.
Participant milestones
| Measure |
Alpelisib + Fulvestrant
Alpelisib 300 mg orally once daily starting on Cycle 1 Day 1 in combination with fulvestrant (intramuscular injection) 500 mg on Cycle 1 Day 1 and Day 15, and Day 1 of every cycle thereafter in a 28 day cycle.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Alpelisib + Fulvestrant
Alpelisib 300 mg orally once daily starting on Cycle 1 Day 1 in combination with fulvestrant (intramuscular injection) 500 mg on Cycle 1 Day 1 and Day 15, and Day 1 of every cycle thereafter in a 28 day cycle.
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Progressive Disease
|
7
|
|
Overall Study
Withdrawal by Subject
|
6
|
Baseline Characteristics
Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment
Baseline characteristics by cohort
| Measure |
Alpelisib + Fulvestrant
n=40 Participants
Alpelisib 300 mg orally once daily starting on Cycle 1 Day 1 in combination with fulvestrant (intramuscular injection) 500 mg on Cycle 1 Day 1 and Day 15, and Day 1 of every cycle thereafter in a 28 day cycle.
|
|---|---|
|
Age, Continuous
|
54.9 Years
STANDARD_DEVIATION 9.71 • n=20 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
40 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 7 monthsPopulation: Safety Population
Treatment-Emergent Adverse Events (TEAEs) were defined as the adverse events that occurred, or worsened, during the treatment period (i.e. from the first dose of treatment up to 30 days after the last dose of study drug).
Outcome measures
| Measure |
Alpelisib + Fulvestrant
n=40 Participants
Alpelisib 300 mg orally once daily starting on Cycle 1 Day 1 in combination with fulvestrant (intramuscular injection) 500 mg on Cycle 1 Day 1 and Day 15, and Day 1 of every cycle thereafter in a 28 day cycle.
|
|---|---|
|
Percentage of Participants With at Least One On-treatment Adverse Events (AEs)
|
100 Percentage of participants
Interval 91.2 to 100.0
|
SECONDARY outcome
Timeframe: From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 7 monthsPopulation: Safety Population
A Serious Adverse Event (SAE) was any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability or incapacity, was a congenital anomaly or birth defect in the offspring of a study participant, or was an abnormal pregnancy outcome.
Outcome measures
| Measure |
Alpelisib + Fulvestrant
n=40 Participants
Alpelisib 300 mg orally once daily starting on Cycle 1 Day 1 in combination with fulvestrant (intramuscular injection) 500 mg on Cycle 1 Day 1 and Day 15, and Day 1 of every cycle thereafter in a 28 day cycle.
|
|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs)
|
25 Percentage of participants
Interval 12.7 to 41.2
|
SECONDARY outcome
Timeframe: From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 7 monthsPopulation: Safety Population
An Adverse Drug Reaction (ADR) was defined as an adverse event (AE) that, in the investigator's judgment, was causally suspected to be related to the study treatment.
Outcome measures
| Measure |
Alpelisib + Fulvestrant
n=40 Participants
Alpelisib 300 mg orally once daily starting on Cycle 1 Day 1 in combination with fulvestrant (intramuscular injection) 500 mg on Cycle 1 Day 1 and Day 15, and Day 1 of every cycle thereafter in a 28 day cycle.
|
|---|---|
|
Percentage of Participants With Adverse Drug Reactions (ADRs)
Subjects with at least one TEAE related to Alpelisib
|
39 Participants
|
|
Percentage of Participants With Adverse Drug Reactions (ADRs)
Subjects with at least one TEAE related to Fulvestrant
|
7 Participants
|
Adverse Events
Alpelisib + Fulvestrant
Serious events: 10 serious events
Other events: 40 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Alpelisib + Fulvestrant
n=40 participants at risk
Alpelisib 300 mg orally once daily starting on Cycle 1 Day 1 in combination with fulvestrant (intramuscular injection) 500 mg on Cycle 1 Day 1 and Day 15, and Day 1 of every cycle thereafter in a 28 day cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
2/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Gastritis
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Stomatitis
|
5.0%
2/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
2/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
General disorders and administration site conditions
Asthenia
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
General disorders and administration site conditions
Fatigue
|
5.0%
2/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.0%
2/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Psychiatric disorders
Completed suicide
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Reproductive system and breast disorders
Breast ulceration
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
2/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
Other adverse events
| Measure |
Alpelisib + Fulvestrant
n=40 participants at risk
Alpelisib 300 mg orally once daily starting on Cycle 1 Day 1 in combination with fulvestrant (intramuscular injection) 500 mg on Cycle 1 Day 1 and Day 15, and Day 1 of every cycle thereafter in a 28 day cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Eye disorders
Vision blurred
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
2/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
2/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Anal incontinence
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Ascites
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Diarrhoea
|
35.0%
14/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Dry mouth
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.5%
3/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Gastritis
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Melaena
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Nausea
|
17.5%
7/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Stomatitis
|
37.5%
15/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
22.5%
9/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
General disorders and administration site conditions
Asthenia
|
10.0%
4/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
General disorders and administration site conditions
Chest discomfort
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
General disorders and administration site conditions
Fatigue
|
12.5%
5/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
General disorders and administration site conditions
Injection site inflammation
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
General disorders and administration site conditions
Mucosal inflammation
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
General disorders and administration site conditions
Oedema
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
General disorders and administration site conditions
Oedema peripheral
|
10.0%
4/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
General disorders and administration site conditions
Pain
|
7.5%
3/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
General disorders and administration site conditions
Pyrexia
|
12.5%
5/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
General disorders and administration site conditions
Swelling face
|
5.0%
2/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Otitis externa
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Urinary tract infection
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Investigations
Blood alkaline phosphatase increased
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Investigations
Blood bilirubin increased
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Investigations
Blood creatinine increased
|
5.0%
2/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Investigations
Electrocardiogram QT prolonged
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.0%
2/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Investigations
Glycosylated haemoglobin increased
|
5.0%
2/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Investigations
Neutrophil count decreased
|
5.0%
2/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Investigations
Platelet count decreased
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Investigations
Weight decreased
|
12.5%
5/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Investigations
White blood cell count decreased
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
8/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
90.0%
36/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
2/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
2/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
2/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Nervous system disorders
Ageusia
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Nervous system disorders
Burning sensation
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Nervous system disorders
Dizziness
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Nervous system disorders
Dysgeusia
|
7.5%
3/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Nervous system disorders
Neuralgia
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Renal and urinary disorders
Pollakiuria
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Renal and urinary disorders
Polyuria
|
5.0%
2/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Reproductive system and breast disorders
Breast swelling
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Reproductive system and breast disorders
Breast ulceration
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Reproductive system and breast disorders
Genital burning sensation
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
4/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.5%
3/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
2.5%
1/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
4/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
2/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
4/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
2/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
|
Vascular disorders
Hypertension
|
7.5%
3/40 • On-treatment Adverse Events (AEs) and deaths were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 7 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER