Trial Outcomes & Findings for Sapanisertib in Combination With Fulvestrant in Women With Advanced or Metastatic Breast Cancer After Aromatase Inhibitor Therapy (NCT NCT02756364)
NCT ID: NCT02756364
Last Updated: 2023-02-08
Results Overview
PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
141 participants
Primary outcome timeframe
Up to 40 months
Results posted on
2023-02-08
Participant Flow
Participants took part in the study at 50 investigative sites in Spain and the United States from 28 July 2016 to 25 November 2019. After all data was collected and participants were transitioned to post-trial access, the Sponsor stopped the study site, defined as 'Site terminated by the Sponsor'.
Female participants with a diagnosis of estrogen receptor (ER)-positive/human epidermal growth factor receptor-2 (HER2)-negative advanced or metastatic breast cancer that has progressed during or after aromatase inhibitor therapy were enrolled in 1:1:1 ratio to receive fulvestrant, fulvestrant + sapanisertib QD and fulvestrant + sapanisertib QW.
Participant milestones
| Measure |
Arm A: Fulvestrant 500 mg
Fulvestrant 500 mg, intramuscularly (IM), once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 16.0 weeks).
|
Arm B: Fulvestrant 500 mg + Sapanisertib 4 mg QD
Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with the sapanisertib 4 mg, capsules, orally, once daily in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 20.1 and 20.3 weeks for fulvestrant and sapanisertib respectively).
|
Arm C: Fulvestrant 500 mg + Sapanisertib 30 mg QW
Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with sapanisertib 30 mg, capsule, orally, once weekly in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 17.0 weeks for fulvestrant and sapanisertib, each).
|
|---|---|---|---|
|
Overall Study
STARTED
|
46
|
47
|
48
|
|
Overall Study
Treated Participants
|
46
|
47
|
47
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
46
|
47
|
48
|
Reasons for withdrawal
| Measure |
Arm A: Fulvestrant 500 mg
Fulvestrant 500 mg, intramuscularly (IM), once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 16.0 weeks).
|
Arm B: Fulvestrant 500 mg + Sapanisertib 4 mg QD
Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with the sapanisertib 4 mg, capsules, orally, once daily in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 20.1 and 20.3 weeks for fulvestrant and sapanisertib respectively).
|
Arm C: Fulvestrant 500 mg + Sapanisertib 30 mg QW
Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with sapanisertib 30 mg, capsule, orally, once weekly in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 17.0 weeks for fulvestrant and sapanisertib, each).
|
|---|---|---|---|
|
Overall Study
Site Terminated by Sponsor
|
24
|
30
|
21
|
|
Overall Study
Death
|
20
|
15
|
18
|
|
Overall Study
Withdrawal by Patient
|
2
|
1
|
8
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
Baseline Characteristics
Sapanisertib in Combination With Fulvestrant in Women With Advanced or Metastatic Breast Cancer After Aromatase Inhibitor Therapy
Baseline characteristics by cohort
| Measure |
Arm A: Fulvestrant 500 mg
n=46 Participants
Fulvestrant 500 mg, intramuscularly (IM), once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 16.0 weeks).
|
Arm B: Fulvestrant 500 mg + Sapanisertib 4 mg QD
n=47 Participants
Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with the sapanisertib 4 mg, capsules, orally, once daily in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 20.1 and 20.3 weeks for fulvestrant and sapanisertib respectively).
|
Arm C: Fulvestrant 500 mg + Sapanisertib 30 mg QW
n=48 Participants
Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with sapanisertib 30 mg, capsule, orally, once weekly in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 17.0 weeks for fulvestrant and sapanisertib, each).
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 10.10 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 10.92 • n=7 Participants
|
57.9 years
STANDARD_DEVIATION 12.04 • n=5 Participants
|
59.5 years
STANDARD_DEVIATION 11.05 • n=4 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
141 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
133 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
23 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 40 monthsPopulation: Full Analysis Set included all randomized participants.
PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Arm A: Fulvestrant 500 mg
n=46 Participants
Fulvestrant 500 mg, intramuscularly (IM), once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 16.0 weeks).
|
Arm B: Fulvestrant 500 mg + Sapanisertib 4 mg QD
n=47 Participants
Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with the sapanisertib 4 mg, capsules, orally, once daily in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 20.1 and 20.3 weeks for fulvestrant and sapanisertib respectively).
|
Arm C: Fulvestrant 500 mg + Sapanisertib 30 mg QW
n=48 Participants
Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with sapanisertib 30 mg, capsule, orally, once weekly in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 17.0 weeks for fulvestrant and sapanisertib, each).
|
|---|---|---|---|
|
Progression Free Survival (PFS)
|
3.5 months
Interval 1.9 to 5.6
|
7.2 months
Interval 3.9 to 10.6
|
5.6 months
Interval 4.1 to 9.0
|
SECONDARY outcome
Timeframe: Up to 164 weeksPopulation: Full Analysis Set included all randomized participants.
OS was defined as the time from the date of randomization to the date of death.
Outcome measures
| Measure |
Arm A: Fulvestrant 500 mg
n=46 Participants
Fulvestrant 500 mg, intramuscularly (IM), once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 16.0 weeks).
|
Arm B: Fulvestrant 500 mg + Sapanisertib 4 mg QD
n=47 Participants
Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with the sapanisertib 4 mg, capsules, orally, once daily in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 20.1 and 20.3 weeks for fulvestrant and sapanisertib respectively).
|
Arm C: Fulvestrant 500 mg + Sapanisertib 30 mg QW
n=48 Participants
Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with sapanisertib 30 mg, capsule, orally, once weekly in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 17.0 weeks for fulvestrant and sapanisertib, each).
|
|---|---|---|---|
|
Overall Survival (OS)
|
30.5 months
Interval 21.5 to
The upper limit of confidence interval (CI) was not estimable due to fewer number of participants with event.
|
NA months
Interval 29.9 to
The median and upper limit of CI was not estimable due to fewer number of participants with event.
|
34.2 months
Interval 20.0 to
The upper limit of CI was not estimable due to fewer number of participants with event.
|
SECONDARY outcome
Timeframe: Up to 40 monthsPopulation: Full Analysis Set included all randomized participants.
TTP was defined as the time from the date of randomization to the date of first documentation of progression. Per RECIST v1.1, PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Arm A: Fulvestrant 500 mg
n=46 Participants
Fulvestrant 500 mg, intramuscularly (IM), once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 16.0 weeks).
|
Arm B: Fulvestrant 500 mg + Sapanisertib 4 mg QD
n=47 Participants
Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with the sapanisertib 4 mg, capsules, orally, once daily in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 20.1 and 20.3 weeks for fulvestrant and sapanisertib respectively).
|
Arm C: Fulvestrant 500 mg + Sapanisertib 30 mg QW
n=48 Participants
Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with sapanisertib 30 mg, capsule, orally, once weekly in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 17.0 weeks for fulvestrant and sapanisertib, each).
|
|---|---|---|---|
|
Time to Progression (TTP)
|
3.5 months
Interval 1.9 to 5.6
|
7.2 months
Interval 5.5 to 10.6
|
5.6 months
Interval 4.1 to 9.0
|
SECONDARY outcome
Timeframe: Up to 40 monthsPopulation: Safety Analysis Set included all participants who received at least 1 dose of study drug.
ORR was defined as the percentage of participants who achieve a best response of complete response (CR) or partial response (PR) according to RECIST v1.1 criteria. CR was defined as disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.
Outcome measures
| Measure |
Arm A: Fulvestrant 500 mg
n=46 Participants
Fulvestrant 500 mg, intramuscularly (IM), once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 16.0 weeks).
|
Arm B: Fulvestrant 500 mg + Sapanisertib 4 mg QD
n=47 Participants
Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with the sapanisertib 4 mg, capsules, orally, once daily in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 20.1 and 20.3 weeks for fulvestrant and sapanisertib respectively).
|
Arm C: Fulvestrant 500 mg + Sapanisertib 30 mg QW
n=47 Participants
Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with sapanisertib 30 mg, capsule, orally, once weekly in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 17.0 weeks for fulvestrant and sapanisertib, each).
|
|---|---|---|---|
|
Objective Response Rate (ORR)
|
10.9 percentage of participants
|
21.3 percentage of participants
|
12.8 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 40 monthsPopulation: Safety Analysis Set included all participants who received at least 1 dose of study drug.
CBR was defined as the percentage of participants who achieved a best response of CR, PR, or stable disease (SD) of any duration. CR was defined as disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
Arm A: Fulvestrant 500 mg
n=46 Participants
Fulvestrant 500 mg, intramuscularly (IM), once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 16.0 weeks).
|
Arm B: Fulvestrant 500 mg + Sapanisertib 4 mg QD
n=47 Participants
Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with the sapanisertib 4 mg, capsules, orally, once daily in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 20.1 and 20.3 weeks for fulvestrant and sapanisertib respectively).
|
Arm C: Fulvestrant 500 mg + Sapanisertib 30 mg QW
n=47 Participants
Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with sapanisertib 30 mg, capsule, orally, once weekly in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 17.0 weeks for fulvestrant and sapanisertib, each).
|
|---|---|---|---|
|
Clinical Benefit Rate (CBR)
|
60.9 percentage of participants
|
74.5 percentage of participants
|
66.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 164 weeksPopulation: Safety Analysis Set included all participants who received at least 1 dose of study drug.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Arm A: Fulvestrant 500 mg
n=46 Participants
Fulvestrant 500 mg, intramuscularly (IM), once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 16.0 weeks).
|
Arm B: Fulvestrant 500 mg + Sapanisertib 4 mg QD
n=47 Participants
Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with the sapanisertib 4 mg, capsules, orally, once daily in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 20.1 and 20.3 weeks for fulvestrant and sapanisertib respectively).
|
Arm C: Fulvestrant 500 mg + Sapanisertib 30 mg QW
n=47 Participants
Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with sapanisertib 30 mg, capsule, orally, once weekly in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 17.0 weeks for fulvestrant and sapanisertib, each).
|
|---|---|---|---|
|
Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)
|
89.1 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
Adverse Events
Arm A: Fulvestrant 500 mg
Serious events: 8 serious events
Other events: 38 other events
Deaths: 20 deaths
Arm B: Fulvestrant 500 mg + Sapanisertib 4 mg QD
Serious events: 13 serious events
Other events: 47 other events
Deaths: 15 deaths
Arm C: Fulvestrant 500 mg + Sapanisertib 30 mg QW
Serious events: 8 serious events
Other events: 47 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Arm A: Fulvestrant 500 mg
n=46 participants at risk
Fulvestrant 500 mg, intramuscularly (IM), once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 16.0 weeks).
|
Arm B: Fulvestrant 500 mg + Sapanisertib 4 mg QD
n=47 participants at risk
Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with the sapanisertib 4 mg, capsules, orally, once daily in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 20.1 and 20.3 weeks for fulvestrant and sapanisertib respectively).
|
Arm C: Fulvestrant 500 mg + Sapanisertib 30 mg QW
n=47 participants at risk
Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with sapanisertib 30 mg, capsule, orally, once weekly in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 17.0 weeks for fulvestrant and sapanisertib, each).
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.3%
2/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
4.3%
2/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.3%
2/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
4.3%
2/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Infections and infestations
Pneumonia
|
2.2%
1/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
4.3%
2/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
4.3%
2/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Nervous system disorders
Encephalopathy
|
2.2%
1/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Nervous system disorders
Headache
|
2.2%
1/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Nervous system disorders
Spinal cord compression
|
2.2%
1/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
General disorders
Pyrexia
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
4.3%
2/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Hepatobiliary disorders
Hepatic failure
|
2.2%
1/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
2.2%
1/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
1/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
1/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
1/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Psychiatric disorders
Disorientation
|
2.2%
1/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
Other adverse events
| Measure |
Arm A: Fulvestrant 500 mg
n=46 participants at risk
Fulvestrant 500 mg, intramuscularly (IM), once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 16.0 weeks).
|
Arm B: Fulvestrant 500 mg + Sapanisertib 4 mg QD
n=47 participants at risk
Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with the sapanisertib 4 mg, capsules, orally, once daily in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 20.1 and 20.3 weeks for fulvestrant and sapanisertib respectively).
|
Arm C: Fulvestrant 500 mg + Sapanisertib 30 mg QW
n=47 participants at risk
Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with sapanisertib 30 mg, capsule, orally, once weekly in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 17.0 weeks for fulvestrant and sapanisertib, each).
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
19.6%
9/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
48.9%
23/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
87.2%
41/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
4/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
29.8%
14/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
70.2%
33/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
1/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
51.1%
24/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
27.7%
13/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Gastrointestinal disorders
Stomatitis
|
6.5%
3/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
34.0%
16/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
31.9%
15/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Gastrointestinal disorders
Constipation
|
17.4%
8/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
8.5%
4/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
12.8%
6/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Gastrointestinal disorders
Dry mouth
|
2.2%
1/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
25.5%
12/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.2%
1/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
10.6%
5/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
19.1%
9/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.5%
3/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
8.5%
4/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
8.5%
4/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
8.5%
4/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
4.3%
2/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
General disorders
Asthenia
|
23.9%
11/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
27.7%
13/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
44.7%
21/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
General disorders
Fatigue
|
21.7%
10/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
36.2%
17/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
23.4%
11/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
General disorders
Pyrexia
|
6.5%
3/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
8.5%
4/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
8.5%
4/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
General disorders
Injection site pain
|
10.9%
5/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
4.3%
2/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
4.3%
2/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
General disorders
Malaise
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
8.5%
4/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
General disorders
Pain
|
2.2%
1/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
21.7%
10/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
57.4%
27/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
55.3%
26/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.9%
5/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
31.9%
15/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
40.4%
19/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.2%
7/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
12.8%
6/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
4.3%
2/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.0%
6/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
8.5%
4/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.9%
5/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
8.5%
4/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.7%
4/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
4.3%
2/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
8.5%
4/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
4.3%
2/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
8.5%
4/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.5%
3/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.7%
4/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Nervous system disorders
Headache
|
19.6%
9/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
8.5%
4/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
21.3%
10/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
17.0%
8/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
14.9%
7/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Nervous system disorders
Dizziness
|
2.2%
1/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
8.5%
4/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
10.6%
5/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
8.5%
4/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Nervous system disorders
Tremor
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
31.9%
15/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
17.0%
8/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
29.8%
14/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
14.9%
7/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Investigations
Electrocardiogram QT prolonged
|
2.2%
1/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.3%
2/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.3%
2/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
4.3%
2/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
4.3%
2/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Investigations
Weight decreased
|
2.2%
1/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
23.4%
11/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
12.8%
6/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Investigations
Aspartate aminotransferase increased
|
4.3%
2/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
12.8%
6/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
12.8%
6/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
4.3%
2/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Investigations
Alanine aminotransferase increased
|
4.3%
2/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
12.8%
6/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
8.5%
4/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.2%
1/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
10.6%
5/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
10.6%
5/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Infections and infestations
Urinary tract infection
|
4.3%
2/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
14.9%
7/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
14.9%
7/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Infections and infestations
Nasopharyngitis
|
8.7%
4/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
10.6%
5/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
2/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
10.6%
5/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Infections and infestations
Respiratory tract infection
|
6.5%
3/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
4.3%
2/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Psychiatric disorders
Anxiety
|
10.9%
5/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
10.6%
5/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
4.3%
2/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Psychiatric disorders
Depression
|
6.5%
3/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
8.5%
4/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
8.5%
4/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.2%
7/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
10.6%
5/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
4.3%
2/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.9%
5/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
14.9%
7/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Vascular disorders
Hypertension
|
15.2%
7/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
8.5%
4/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
10.6%
5/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Vascular disorders
Hot flush
|
10.9%
5/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
2.1%
1/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.5%
3/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
4.3%
2/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
4.3%
2/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/46 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
6.4%
3/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
0.00%
0/47 • Up to 164 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause Mortality or data for deaths were collected in FAS population. Adverse events were collected in Safety Analysis Set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
- Publication restrictions are in place
Restriction type: OTHER