Trial Outcomes & Findings for Study Of Oral PHA-848125AC In Patients With Malignant Thymoma Previously Treated With Multiple Lines Of Chemotherapy (NCT NCT01301391)
NCT ID: NCT01301391
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
30 participants
Primary outcome timeframe
3 months since treatment start
Results posted on
2019-02-06
Participant Flow
Subjects were enrolled from 02 Feb 2011 to 28 Jan 2016 by 2 centers in US and one in Italy.
Four patients were screening failure.
Participant milestones
| Measure |
Milciclib
Milciclib Maleate capsules
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
|
30
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
Milciclib
Milciclib Maleate capsules
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
|
13
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Sponsor's decision
|
8
|
Baseline Characteristics
Study Of Oral PHA-848125AC In Patients With Malignant Thymoma Previously Treated With Multiple Lines Of Chemotherapy
Baseline characteristics by cohort
| Measure |
Milciclib
n=30 Participants
Milciclib Maleate capsules
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=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
54.2 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Listed
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
15 Participants
n=5 Participants
|
|
World Health Organization classification (International Classification of Diseases)
B3 - Well Differentiated Thymic Carcinoma
|
17 Participants
n=5 Participants
|
|
World Health Organization classification (International Classification of Diseases)
C - Thymic Carcinoma
|
13 Participants
n=5 Participants
|
|
Tumor extent at study entry
Metastatic
|
30 Participants
n=5 Participants
|
|
Tumor extent at study entry
In situ
|
0 Participants
n=5 Participants
|
|
Masaoka clinical staging at study entry
Stage I: Grossly and microscopically encapsulate
|
0 Participants
n=5 Participants
|
|
Masaoka clinical staging at study entry
Stage II: Thymoma invades beyond the capsule
|
0 Participants
n=5 Participants
|
|
Masaoka clinical staging at study entry
Stage III: Macroscopic invasion neighboring organs
|
0 Participants
n=5 Participants
|
|
Masaoka clinical staging at study entry
Stage IVA: Pleural or pericardial dissemination
|
7 Participants
n=5 Participants
|
|
Masaoka clinical staging at study entry
Stage IVB: Hematogenous or lymphatic dissemination
|
10 Participants
n=5 Participants
|
|
Masaoka clinical staging at study entry
Not assessed
|
6 Participants
n=5 Participants
|
|
Masaoka clinical staging at study entry
Not available
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months since treatment startPopulation: Evaluable patients, i.e., consists of all eligible and treated patients who fulfill the following additional conditions: 1) they receive at least 80% of drug in the first two cycles overall; 2) they have baseline and \> or = 1 on-treatment tumor/oncologic assessment(s) 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
n=24 Participants
Milciclib Maleate capsules
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
|
13 Participants
|
|
Progression-free Survival Rate at 3 Months
Failure
|
11 Participants
|
SECONDARY outcome
Timeframe: Adverse events: from date treatment consent signed to 28 days after last treatment; hematology/blood chemistry tests: at baseline and between Day 11-14 of each cycle of a maximum total of 48 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 were evaluated by considering the worst occurrence for each patient throughout the whole treatment period.
Outcome measures
| Measure |
Milciclib
n=30 Participants
Milciclib Maleate capsules
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.
|
|---|---|
|
Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters
N° patients with Adverse Events
|
30 Participants
|
|
Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters
N° patients with abnormal Hematology test
|
28 Participants
|
|
Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters
N° patients with abnormal Blood chemistry test
|
27 Participants
|
SECONDARY outcome
Timeframe: Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.Population: Evaluable population: the patient population consists of all eligible and treated patients who fulfill the following additional conditions: 1) they receive at least 80% of drug in the first two cycles overall; 2) they have baseline and \> or = 1 on-treatment tumor/oncologic assessment(s) or die before tumor re-assessment.
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
n=24 Participants
Milciclib Maleate capsules
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.
|
|---|---|
|
Objective Response Rate (ORR)
|
4.2 Percentage of patients
Interval 0.11 to 21.12
|
SECONDARY outcome
Timeframe: Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.Population: Evaluable patients
Point and 95% confidence interval estimates was calculated for the disease control rate (confirmed CRs / PRs and SD \> or = 6 weeks). The analysis was performed in the evaluable patient populations.
Outcome measures
| Measure |
Milciclib
n=24 Participants
Milciclib Maleate capsules
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 (ORR+SD Rate)
|
83.3 Percentage of patients
Interval 62.62 to 95.26
|
SECONDARY outcome
Timeframe: Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.Population: Patients achieving a confirmed objective tumor response by RECIST version 1.1 criteria.
Calculated in patients achieving a confirmed objective tumor response by RECIST version 1.1 criteria.
Outcome measures
| Measure |
Milciclib
n=1 Participants
Milciclib Maleate capsules
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
|
2.76 Months
|
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 either the date of diagnosis or the start of treatment for a disease, such as cancer, and to the date in which the patients diagnosed with the disease are still alive. Kaplan-Meier estimates as percentage of patients alive.
Outcome measures
| Measure |
Milciclib
n=24 Participants
Milciclib Maleate capsules
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
|
41.666 percentage of patients dead at 21 months
|
SECONDARY outcome
Timeframe: Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.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
n=24 Participants
Milciclib Maleate capsules
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 (PFS)
|
9.76 Months
Interval 4.11 to 17.45
|
Adverse Events
Milciclib
Serious events: 14 serious events
Other events: 28 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Milciclib
n=30 participants at risk
Milciclib Maleate capsules
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.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Haemoptisys
|
6.7%
2/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea NOS
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction NOS
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Infections and infestations
Pneumonia NOS
|
6.7%
2/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Infections and infestations
Sepsis NOS
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Nervous system disorders
Extrapyramidal disorder
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Nervous system disorders
Syncope
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Skin and subcutaneous tissue disorders
Sweating increased
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Cardiac disorders
Pericardial effusion
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
General disorders
Fatigue
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
General disorders
Pyrexia
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Injury, poisoning and procedural complications
Fracture
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Investigations
Blood alkaline phosphatase NOS increased
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Investigations
Blood bilirubin increased
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Reproductive system and breast disorders
Epididymitis NOS
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Vascular disorders
Deep vein thrombosis
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Infections and infestations
Staphylococcal infection
|
3.3%
1/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
Other adverse events
| Measure |
Milciclib
n=30 participants at risk
Milciclib Maleate capsules
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
|
83.3%
25/30 • Number of events 92 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
60.0%
18/30 • Number of events 70 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Gastrointestinal disorders
Vomiting NOS
|
56.7%
17/30 • Number of events 66 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Gastrointestinal disorders
Constipation
|
13.3%
4/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
3/30 • Number of events 3 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
6.7%
2/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
2/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal disorder NOS
|
6.7%
2/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
General disorders
Asthenia
|
36.7%
11/30 • Number of events 22 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
General disorders
Fatigue
|
36.7%
11/30 • Number of events 17 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
General disorders
Pyrexia
|
23.3%
7/30 • Number of events 9 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
General disorders
Oedema peripheral
|
16.7%
5/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
General disorders
Chest pain
|
10.0%
3/30 • Number of events 3 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
General disorders
Pain NOS
|
6.7%
2/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
General disorders
Pain exacerbated
|
6.7%
2/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Nervous system disorders
Tremor
|
36.7%
11/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Nervous system disorders
Dizziness
|
23.3%
7/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Nervous system disorders
Paraesthesia
|
13.3%
4/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Nervous system disorders
Dysgeusia
|
10.0%
3/30 • Number of events 3 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Nervous system disorders
Haedache
|
10.0%
3/30 • Number of events 3 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
6/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea NOS
|
6.7%
2/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.7%
2/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
2/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.7%
2/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Metabolism and nutrition disorders
Anorexia
|
26.7%
8/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Metabolism and nutrition disorders
Appetite decreased NOS
|
6.7%
2/30 • Number of events 3 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Metabolism and nutrition disorders
Dehydratation
|
6.7%
2/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.7%
2/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.7%
2/30 • Number of events 3 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.7%
2/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Investigations
Lipase increased
|
13.3%
4/30 • Number of events 11 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
3/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Investigations
Blood amylase increased
|
10.0%
3/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Investigations
Weight decreased
|
10.0%
3/30 • Number of events 3 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
2/30 • Number of events 3 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Investigations
Lymphocyte count decreased
|
6.7%
2/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
4/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.7%
2/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.7%
2/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
2/30 • Number of events 3 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
3/30 • Number of events 3 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
3/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
2/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Skin and subcutaneous tissue disorders
Nail disorder NOS
|
6.7%
2/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Blood and lymphatic system disorders
Anaemia
|
26.7%
8/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Blood and lymphatic system disorders
Leukopenia
|
13.3%
4/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.3%
4/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Eye disorders
Conjunctivitis
|
6.7%
2/30 • Number of events 3 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Eye disorders
Ocular discomfort
|
6.7%
2/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Eye disorders
Photopsia
|
6.7%
2/30 • Number of events 3 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Infections and infestations
Influenza
|
10.0%
3/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.7%
2/30 • Number of events 3 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Renal and urinary disorders
Azotaemia
|
6.7%
2/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Psychiatric disorders
Anxiety
|
6.7%
2/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
|
Cardiac disorders
Tachycardia
|
6.7%
2/30 • 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 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60