Trial Outcomes & Findings for Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib (NCT NCT00644878)
NCT ID: NCT00644878
Last Updated: 2021-08-18
Results Overview
The change on a logarithmic scale at 12 months from a standardized baseline value (100% on the international scale \[IS\]) in Bcr-Abl transcripts as assessed by peripheral blood Quantitative real-time polymerase chain reaction (RQ-PCR).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
From Baseline up to 12 Months
Results posted on
2021-08-18
Participant Flow
The study was conducted at 12 centers in United States.
A total of 18 participants was enrolled in this study. Due to slower than expected enrollment, the study was terminated on 31 March 2012.
Participant milestones
| Measure |
Nilotinib
Participants orally received a total of 600 milligram (mg) dose of Nilotinib as 50-mg and 200-mg hard gelatin capsules twice daily (BID) for 12 cycles (each cycle = 28 days).
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Nilotinib
Participants orally received a total of 600 milligram (mg) dose of Nilotinib as 50-mg and 200-mg hard gelatin capsules twice daily (BID) for 12 cycles (each cycle = 28 days).
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Abnormal laboratory value
|
3
|
|
Overall Study
Protocol deviation
|
2
|
|
Overall Study
Treatment duration completed as per protocol
|
11
|
Baseline Characteristics
Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib
Baseline characteristics by cohort
| Measure |
Nilotinib
n=18 Participants
Participants orally received a total of 600 mg dose of Nilotinib as 50-mg and 200-mg hard gelatin capsules BID for 12 cycles (each cycle = 28 days).
|
|---|---|
|
Age, Continuous
|
45.7 years
STANDARD_DEVIATION 12.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline up to 12 MonthsPopulation: The analysis was performed in intent-to-treat (ITT) population, defined as all enrolled participants who received at least 1 dose of study drug and had at least 1 post-baseline assessment. Here, number of participants analyzed refer to the number of participants evaluable for this outcome measure at specified time point.
The change on a logarithmic scale at 12 months from a standardized baseline value (100% on the international scale \[IS\]) in Bcr-Abl transcripts as assessed by peripheral blood Quantitative real-time polymerase chain reaction (RQ-PCR).
Outcome measures
| Measure |
Nilotinib
n=18 Participants
Participants orally received a total of 600 mg dose of Nilotinib as 50-mg and 200-mg hard gelatin capsules BID for 12 cycles (each cycle = 28 days).
|
|---|---|
|
Log Change From Baseline in Breakpoint Cluster Region Gene (BCR) - Abelson Proto-oncogene (ABL) (Bcr-Abl) Transcript Levels
Baseline
|
2.229 log change
Standard Deviation 0.6165
|
|
Log Change From Baseline in Breakpoint Cluster Region Gene (BCR) - Abelson Proto-oncogene (ABL) (Bcr-Abl) Transcript Levels
Month 12
|
3.612 log change
Standard Deviation 0.5689
|
SECONDARY outcome
Timeframe: From Baseline up to 12 MonthsPopulation: The analysis was performed in ITT population, defined as all enrolled participants who received at least 1 dose of study drug and had at least 1 post-baseline assessment.
Major Molecular Response (MMR) value at molecular MD is designated a percentage, which is equivalent to a 3-log reduction from a standardized baseline value from the International Randomized InteYesrferon versus STI571 (IRIS) study or 0.1 percent (%) per International Scale (IS).
Outcome measures
| Measure |
Nilotinib
n=18 Participants
Participants orally received a total of 600 mg dose of Nilotinib as 50-mg and 200-mg hard gelatin capsules BID for 12 cycles (each cycle = 28 days).
|
|---|---|
|
Number of Participants Who Achieved Major Molecular Response (MMR)
Baseline · Response: Yes
|
0 Participants
|
|
Number of Participants Who Achieved Major Molecular Response (MMR)
Baseline · Response: No
|
18 Participants
|
|
Number of Participants Who Achieved Major Molecular Response (MMR)
Baseline · Response: Missing
|
0 Participants
|
|
Number of Participants Who Achieved Major Molecular Response (MMR)
Month 12 · Response: Yes
|
9 Participants
|
|
Number of Participants Who Achieved Major Molecular Response (MMR)
Month 12 · Response: No
|
3 Participants
|
|
Number of Participants Who Achieved Major Molecular Response (MMR)
Month 12 · Response: Missing
|
6 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to 12 MonthsPopulation: The analysis was performed in ITT population, defined as all enrolled participants who received at least 1 dose of study drug and had at least 1 post-baseline assessment. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.
Number of participants experiencing either a greater than or equal to (\>or=) 1, \>or= 2, or \>or= 3 log10 reduction in Bcr-Abl transcript levels from Baseline to End of Cycle (EOC) 45 (Day1219 - Day1302) were presented.
Outcome measures
| Measure |
Nilotinib
n=12 Participants
Participants orally received a total of 600 mg dose of Nilotinib as 50-mg and 200-mg hard gelatin capsules BID for 12 cycles (each cycle = 28 days).
|
|---|---|
|
Number of Participants Achieved Reduction From a Standardized Baseline Value in Bcr-Abl Transcript Levels up to Month 12
>or=1 log10 reduction
|
12 Participants
|
|
Number of Participants Achieved Reduction From a Standardized Baseline Value in Bcr-Abl Transcript Levels up to Month 12
>or= 2 log10 reduction
|
12 Participants
|
|
Number of Participants Achieved Reduction From a Standardized Baseline Value in Bcr-Abl Transcript Levels up to Month 12
>or= 3 log10
|
9 Participants
|
SECONDARY outcome
Timeframe: From Start of Study up to End of the Study (up to 41 Months)Population: The analysis was performed in ITT population, defined as all enrolled participants who received at least 1 dose of study drug and had at least 1 post-baseline assessment.
The median time to best molecular response, defined as the time (in months) from the date of enrollment to the date when the maximum reduction in Bcr-Abl transcript level was observed.
Outcome measures
| Measure |
Nilotinib
n=18 Participants
Participants orally received a total of 600 mg dose of Nilotinib as 50-mg and 200-mg hard gelatin capsules BID for 12 cycles (each cycle = 28 days).
|
|---|---|
|
Median Time to Best Molecular Response
|
13.8 months
Interval 4.2 to 23.1
|
SECONDARY outcome
Timeframe: From Start of Study up to End of the Study (up to 41 Months)Population: Since only one participant met the criterion of losing response (that is \[i.e.,\] an increase in \> 1 log10 is observed after the occurrence of best molecular response), the analysis was not performed. Hence data was not collected and reported.
Duration of best molecular response, defined as the time (in months) from the date of best molecular response to a date when an increase in \>1 log10 was observed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Start of Study up to End of the Study (up to 41 Months)Population: The analysis was performed in ITT population, defined as all enrolled participants who received at least 1 dose of study drug and had at least 1 post-baseline assessment. Participants who did not have an event or dropped out without an event are considered censored at the date of the last observed event.
Event-free survival was defined as the number of participants from the date of enrollment to the date of first occurrence of any of the following: loss of complete hematological response (CHR), loss of Complete cytogenetic response (CCyR), \>1 log increase in Bcr-Abl transcripts from the lowest recorded value, progression to accelerated or blast phase, and death.
Outcome measures
| Measure |
Nilotinib
n=18 Participants
Participants orally received a total of 600 mg dose of Nilotinib as 50-mg and 200-mg hard gelatin capsules BID for 12 cycles (each cycle = 28 days).
|
|---|---|
|
Number of Participants With an Event-free Survival
Event
|
1 Participants
|
|
Number of Participants With an Event-free Survival
Censor
|
17 Participants
|
SECONDARY outcome
Timeframe: From Start of Study up to End of the Study (up to 41 Months)Population: The analysis was performed in ITT population, defined as all enrolled participants who received at least 1 dose of study drug and had at least 1 post-baseline assessment.
Progression-free survival was defined as the number of participants from the date of enrollment to the date of first occurrence of progression to Accelerated phase (AP) or Blast crisis (BC) phase, chronic myelogenous leukemia (CML) or death. Participants who did not have an event or dropped out without an event are considered censored at the date of the last observed event.
Outcome measures
| Measure |
Nilotinib
n=18 Participants
Participants orally received a total of 600 mg dose of Nilotinib as 50-mg and 200-mg hard gelatin capsules BID for 12 cycles (each cycle = 28 days).
|
|---|---|
|
Number of Participants With a Progression-free Survival
Censor
|
15 Participants
|
|
Number of Participants With a Progression-free Survival
Missing
|
3 Participants
|
SECONDARY outcome
Timeframe: From Start of Study Enrollment up to End of the Study (up to 41 Months)Population: The analysis was performed in ITT population, defined as all enrolled participants who received at least 1 dose of study drug and had at least 1 post-baseline assessment.
Overall survival was defined as the number of participants from enrollment to the date of death.
Outcome measures
| Measure |
Nilotinib
n=18 Participants
Participants orally received a total of 600 mg dose of Nilotinib as 50-mg and 200-mg hard gelatin capsules BID for 12 cycles (each cycle = 28 days).
|
|---|---|
|
Number of Participants With an Overall Survival
|
18 Participants
|
Adverse Events
Nilotinib
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nilotinib
n=18 participants at risk
Participants orally received a total of 600 mg dose of Nilotinib as a as 50-mg and 200-mg hard gelatin capsules BID for 12 cycles (each cycle = 28 days).
|
|---|---|
|
Cardiac disorders
Bradycardia
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Ear and labyrinth disorders
Vertigo
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Pancreatitis
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Pneumonia
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Sinusitis
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
Other adverse events
| Measure |
Nilotinib
n=18 participants at risk
Participants orally received a total of 600 mg dose of Nilotinib as a as 50-mg and 200-mg hard gelatin capsules BID for 12 cycles (each cycle = 28 days).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Tachycardia
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Ear and labyrinth disorders
Ear pain
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Eye disorders
Dry eye
|
16.7%
3/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Eye disorders
Eye irritation
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Eye disorders
Eye pruritus
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Eye disorders
Macular degeneration
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Eye disorders
Vision blurred
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Anal pruritus
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Colitis
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
3/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Flatulence
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Gingival bleeding
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Gingival pain
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
22.2%
4/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Proctalgia
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Toothache
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
2/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
Asthenia
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
Fatigue
|
33.3%
6/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
Irritability
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
Swelling
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
11.1%
2/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Immune system disorders
Seasonal allergy
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Bronchitis
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Cystitis
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Eye infection
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Folliculitis
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Genital herpes
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
2/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Sinusitis
|
22.2%
4/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Tinea infection
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
22.2%
4/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Sunburn
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
3/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
2/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
Blood bilirubin increased
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
Blood glucose increased
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
Blood magnesium increased
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
Blood phosphorus decreased
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
Blood potassium decreased
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
Blood pressure increased
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
Blood uric acid increased
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
Platelet count decreased
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
Weight decreased
|
11.1%
2/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
Weight increased
|
11.1%
2/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
11.1%
2/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.1%
2/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
11.1%
2/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
27.8%
5/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
3/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
22.2%
4/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
2/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Headache
|
27.8%
5/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Hyperaesthesia
|
11.1%
2/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Paraesthesia
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Speech disorder
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Tremor
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Confusional state
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Depression
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Insomnia
|
11.1%
2/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Loss of libido
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Bladder prolapse
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Micturition urgency
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Urinary retention
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Reproductive system and breast disorders
Breast tenderness
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
4/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
3/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
3/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
2/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
16.7%
3/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
2/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.8%
5/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
11.1%
2/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Hypertension
|
11.1%
2/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • From Start of Study to End of the Study (up to 41 Months)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place