Trial Outcomes & Findings for Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma (NCT NCT01011439)
NCT ID: NCT01011439
Last Updated: 2019-02-06
Results Overview
The proportion of successes (i.e. patients alive and progression free at 3 months since treatment start) out of the total number of evaluable patients
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
3 months since treatment start
Results posted on
2019-02-06
Participant Flow
Subjects were enrolled from 22 February 2010 to 05 April 2016
Participant milestones
| Measure |
Milciclib Maleate (PHA-848125AC)
100 and 50 mg Capsule 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle
Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.
Number of cycles: until disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
72
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
57
|
Reasons for withdrawal
| Measure |
Milciclib Maleate (PHA-848125AC)
100 and 50 mg Capsule 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle
Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.
Number of cycles: until disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Death
|
37
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Sponsor's decision
|
15
|
Baseline Characteristics
Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma
Baseline characteristics by cohort
| Measure |
Milciclib Maleate (PHA-848125AC)
n=72 Participants
100 and 50 mg Capsule 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle
Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.
Number of cycles: until disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
57 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=93 Participants
|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 13.3 • n=93 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
50 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Not Listed
|
10 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Not allowed to ask per local regulation
|
6 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=93 Participants
|
|
Region of Enrollment
Italy
|
36 participants
n=93 Participants
|
|
Region of Enrollment
France
|
23 participants
n=93 Participants
|
|
WHO - Classification
B3 - Well differantiated thymic carcinoma
|
20 Participants
n=93 Participants
|
|
WHO - Classification
C - Thymic Carcinoma
|
52 Participants
n=93 Participants
|
|
Tumor extent at study entry
Locally advanced
|
1 Participants
n=93 Participants
|
|
Tumor extent at study entry
Metastatic
|
71 Participants
n=93 Participants
|
|
Masaoka clinical staging at study entry
Stage I: grossly and microscopically encapsulated
|
0 Participants
n=93 Participants
|
|
Masaoka clinical staging at study entry
Stage II: thymoma invades beyond the capsule
|
0 Participants
n=93 Participants
|
|
Masaoka clinical staging at study entry
Stage III: macroscopic invasion neighboring organs
|
1 Participants
n=93 Participants
|
|
Masaoka clinical staging at study entry
Stage IV A: pleural or pericardial dissemination
|
13 Participants
n=93 Participants
|
|
Masaoka clinical staging at study entry
Stage IVB:hematogeneous or lymphatic dissemination
|
51 Participants
n=93 Participants
|
|
Masaoka clinical staging at study entry
Not Listed
|
7 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 3 months since treatment startPopulation: Evaluable patients: population consisting of all treated patients who fulfill the following conditions: * histological confirmation of thymic carcinoma by an Independent Review Committee * received at least 80% of drug in the first two cycles overall * baseline and \>/= 1 on treatment tumor assessment or die before tumor re-assessment
The proportion of successes (i.e. patients alive and progression free at 3 months since treatment start) out of the total number of evaluable patients
Outcome measures
| Measure |
Milciclib Maleate (PHA-848125AC)
n=54 Participants
100 and 50 mg Capsule 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle
Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.
Number of cycles: until disease progression or unacceptable toxicity.
|
|---|---|
|
Progression-free Survival Rate at 3 Months
Success
|
24 Participants
|
|
Progression-free Survival Rate at 3 Months
Failure
|
30 Participants
|
SECONDARY outcome
Timeframe: Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD.Population: Evaluable patients
Point and 95% confidence interval estimates was calculated for the objective tumor response rate (confirmed CRs or PRs). The determination of antitumor efficacy was based on objective tumor assessments made according to the RECIST guideline (version 1.1) The analysis was performed in the evaluable population.
Outcome measures
| Measure |
Milciclib Maleate (PHA-848125AC)
n=54 Participants
100 and 50 mg Capsule 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle
Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.
Number of cycles: until disease progression or unacceptable toxicity.
|
|---|---|
|
Confirmed Objective Response Rate (ORR)
|
3.7 Percentage of patients
Interval 0.45 to 12.75
|
SECONDARY outcome
Timeframe: Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD.Population: Evaluable patients
Point and 95% confidence interval estimates was calculated for the disease control rate (confirmed CRs / PRs and SD\>/= 6 weeks). The analysis was performed in the evaluable populations.
Outcome measures
| Measure |
Milciclib Maleate (PHA-848125AC)
n=54 Participants
100 and 50 mg Capsule 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle
Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.
Number of cycles: until disease progression or unacceptable toxicity.
|
|---|---|
|
Disease Control Rate
|
75.9 Percentage of patients
Interval 62.36 to 86.51
|
SECONDARY outcome
Timeframe: Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD.Population: Evaluable patients
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works.
Outcome measures
| Measure |
Milciclib Maleate (PHA-848125AC)
n=54 Participants
100 and 50 mg Capsule 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle
Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.
Number of cycles: until disease progression or unacceptable toxicity.
|
|---|---|
|
Progression-free Survival
|
6.83 Months
Interval 4.11 to 8.71
|
SECONDARY outcome
Timeframe: Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD.Assessed in patients achieving a confirmed objective tumor response by RECIST version 1.1 criteria.
Outcome measures
| Measure |
Milciclib Maleate (PHA-848125AC)
n=2 Participants
100 and 50 mg Capsule 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle
Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.
Number of cycles: until disease progression or unacceptable toxicity.
|
|---|---|
|
Duration of Response
|
8.41 Months
Interval 6.9 to 9.92
|
SECONDARY outcome
Timeframe: Every 6 weeks during Follow-Up until PD or new therapy start; every 6 months thereafter, up to 2 years from the last dose of study drug.Population: Evaluable patients
The length of time from the start of treatment for a disease, such as cancer, to the date in which the patients diagnosed with the disease were still alive.
Outcome measures
| Measure |
Milciclib Maleate (PHA-848125AC)
n=54 Participants
100 and 50 mg Capsule 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle
Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.
Number of cycles: until disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
24.18 Months
Interval 16.89 to 36.57
|
SECONDARY outcome
Timeframe: Adverse events: from date treatment consent signed to 28 days after last dose of study drug; hematology/blood chemistry tests: at baseline and between Day 11-14 of each cycle of a total of 135 two-week cycles.Population: All treated patients
The adverse events (AEs) were coded with the Medical Dictionary for Regulatory Activities (MedDRA) and their severity graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The following subsets of AEs were considered: serious AEs, AEs with CTCAE grade 3-5, AEs with a relationship to study treatment classified by the Investigator as possible or probable or definite and AEs reported as leading to discontinuation from treatment. Laboratory test values were graded according to the NCI CTCAE scale, v3.0, whenever possible. For each laboratory test included in the NCI CTCAE system, the incidence of abnormalities was evaluated by considering the worst occurrence for each patient throughout the whole treatment period.
Outcome measures
| Measure |
Milciclib Maleate (PHA-848125AC)
n=72 Participants
100 and 50 mg Capsule 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle
Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.
Number of cycles: until disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Safety Profile (Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters)
N° patients with Adverse Events
|
72 Participants
|
|
Overall Safety Profile (Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters)
N° patients with abnormal Hematology test
|
70 Participants
|
|
Overall Safety Profile (Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters)
N° patients with abnormal Blood Chemistry test
|
70 Participants
|
Adverse Events
Milciclib Maleate (PHA-848125AC)
Serious events: 22 serious events
Other events: 72 other events
Deaths: 37 deaths
Serious adverse events
| Measure |
Milciclib Maleate (PHA-848125AC)
n=72 participants at risk
100 and 50 mg Capsule 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle
Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.
Number of cycles: until disease progression or unacceptable toxicity.
|
|---|---|
|
Nervous system disorders
Syncope
|
2.8%
2/72 • Number of events 2 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Nervous system disorders
Cerebral ischaemia
|
1.4%
1/72 • Number of events 1 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Nervous system disorders
Epilepsy NOS
|
1.4%
1/72 • Number of events 1 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Nervous system disorders
Muscle contractions involuntary
|
1.4%
1/72 • Number of events 2 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Nervous system disorders
Myasthenia gravis
|
1.4%
1/72 • Number of events 1 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Nervous system disorders
Myasthenic syndrome
|
1.4%
1/72 • Number of events 1 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Nervous system disorders
Neuralgia NOS
|
1.4%
1/72 • Number of events 1 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Nervous system disorders
Neurological symptoms
|
1.4%
1/72 • Number of events 1 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
General disorders
Pyrexia
|
2.8%
2/72 • Number of events 2 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
General disorders
Sudden death
|
2.8%
2/72 • Number of events 2 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
General disorders
Asthenia
|
1.4%
1/72 • Number of events 1 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
General disorders
Oedema peripheral
|
1.4%
1/72 • Number of events 1 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.8%
2/72 • Number of events 2 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis NOS
|
1.4%
1/72 • Number of events 1 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea NOS
|
1.4%
1/72 • Number of events 1 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/72 • Number of events 1 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.4%
1/72 • Number of events 1 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
2/72 • Number of events 2 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
2/72 • Number of events 2 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/72 • Number of events 1 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Blood and lymphatic system disorders
Red cell aplasia
|
1.4%
1/72 • Number of events 1 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Eye disorders
Retinal detachment
|
1.4%
1/72 • Number of events 1 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Hepatobiliary disorders
Biliary dilatation
|
1.4%
1/72 • Number of events 1 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Infections and infestations
Infection NOS
|
1.4%
1/72 • Number of events 1 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Metabolism and nutrition disorders
Dehydratation
|
1.4%
1/72 • Number of events 1 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Musculoskeletal and connective tissue disorders
Polymyositis
|
1.4%
1/72 • Number of events 1 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Psychiatric disorders
Confusional state
|
1.4%
1/72 • Number of events 1 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.4%
1/72 • Number of events 1 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Vascular disorders
Subclavian vein thrombosis
|
1.4%
1/72 • Number of events 1 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Vascular disorders
Superior vena caval occclusion
|
1.4%
1/72 • Number of events 1 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
Other adverse events
| Measure |
Milciclib Maleate (PHA-848125AC)
n=72 participants at risk
100 and 50 mg Capsule 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle
Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.
Number of cycles: until disease progression or unacceptable toxicity.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
90.3%
65/72 • Number of events 448 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
77.8%
56/72 • Number of events 457 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Gastrointestinal disorders
Vomiting NOS
|
65.3%
47/72 • Number of events 192 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
15.3%
11/72 • Number of events 28 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
8/72 • Number of events 10 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
8/72 • Number of events 15 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Gastrointestinal disorders
Dysphagia
|
5.6%
4/72 • Number of events 4 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Gastrointestinal disorders
Stomatitis
|
5.6%
4/72 • Number of events 5 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
General disorders
Asthenia
|
66.7%
48/72 • Number of events 249 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
General disorders
Chest pain
|
19.4%
14/72 • Number of events 30 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
General disorders
Fatigue
|
19.4%
14/72 • Number of events 34 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
General disorders
Pyrexia
|
13.9%
10/72 • Number of events 13 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
General disorders
Mucosal imflammation
|
9.7%
7/72 • Number of events 14 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
General disorders
Oedema peripheral
|
6.9%
5/72 • Number of events 10 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
General disorders
Rigors
|
6.9%
5/72 • Number of events 5 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Nervous system disorders
Tremor
|
34.7%
25/72 • Number of events 159 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Nervous system disorders
Headache
|
20.8%
15/72 • Number of events 34 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Nervous system disorders
Dysgeusia
|
18.1%
13/72 • Number of events 37 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Nervous system disorders
Dizziness
|
16.7%
12/72 • Number of events 28 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Nervous system disorders
Paraesthesia
|
11.1%
8/72 • Number of events 10 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Nervous system disorders
Dysphonia
|
8.3%
6/72 • Number of events 6 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Metabolism and nutrition disorders
Anorexia
|
31.9%
23/72 • Number of events 45 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
23.6%
17/72 • Number of events 72 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
24/72 • Number of events 35 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
27.8%
20/72 • Number of events 28 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis NOS
|
12.5%
9/72 • Number of events 13 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
8.3%
6/72 • Number of events 10 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.8%
15/72 • Number of events 19 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
12/72 • Number of events 15 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.9%
5/72 • Number of events 5 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.6%
4/72 • Number of events 5 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.6%
4/72 • Number of events 5 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
9/72 • Number of events 12 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Investigations
Blood amylase increased
|
11.1%
8/72 • Number of events 32 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Investigations
Lipase increased
|
9.7%
7/72 • Number of events 33 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
6/72 • Number of events 7 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Investigations
Weight decreased
|
6.9%
5/72 • Number of events 5 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Eye disorders
Photopsia
|
9.7%
7/72 • Number of events 14 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Eye disorders
Vision blurred
|
8.3%
6/72 • Number of events 6 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Eye disorders
Conjunctivitis
|
6.9%
5/72 • Number of events 8 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Eye disorders
Lacrimation increased
|
5.6%
4/72 • Number of events 5 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Eye disorders
Visual disturbance NOS
|
5.6%
4/72 • Number of events 5 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Blood and lymphatic system disorders
Leukopenia NOS
|
16.7%
12/72 • Number of events 32 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
12/72 • Number of events 39 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Blood and lymphatic system disorders
Anaemia NOS
|
11.1%
8/72 • Number of events 12 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash NOS
|
6.9%
5/72 • Number of events 5 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Skin and subcutaneous tissue disorders
Sweating increased
|
5.6%
4/72 • Number of events 7 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Psychiatric disorders
Anxiety
|
8.3%
6/72 • Number of events 12 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Psychiatric disorders
Insomnia
|
8.3%
6/72 • Number of events 12 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Psychiatric disorders
Depression
|
5.6%
4/72 • Number of events 5 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Ear and labyrinth disorders
Vertigo
|
13.9%
10/72 • Number of events 108 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Infections and infestations
Influenza
|
5.6%
4/72 • Number of events 7 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
|
Cardiac disorders
Palpitations
|
5.6%
4/72 • Number of events 6 • Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60