Trial Outcomes & Findings for Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options (NCT NCT03583164)
NCT ID: NCT03583164
Last Updated: 2024-07-10
Results Overview
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) criteria. For the primary statistical analysis of overall response rate, values were assigned to the DRC adjudicated overall response as follows: Success (Success-Complete, Success-Partial); Failure (Failure-Stable, Failure-Progression, Death, and participants for whom data at the Day 42 Study Visit could not be collected or participants who were considered not evaluable at the Day 42 Study Visit).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
203 participants
Primary outcome timeframe
Day 42 in the Main Phase of study treatment
Results posted on
2024-07-10
Participant Flow
This study planned to enrol approximately 200 patients at approximately 100 centres globally over at least 60 months. The first patient was enrolled into the study on 06 June 2018 and the Last subject last visit date was 10 February 2023 (for the Extended Treatment Phase).
Participant milestones
| Measure |
Olorofim (F901318)
Open-label single-arm of F901318 (olorofim) as treatment of invasive fungal infections due to Lomentospora prolificans, Scedosporium spp., Aspergillus spp., and other resistant fungi which are susceptible to F901318 in patients with limited treatment options.
Olorofim 30 mg tablets were given for up to 90 days in the Main Study Phase and could be continued for those entering the Extended Treatment Phase.
Patients received a 1-day loading dose of 150 mg of olorofim twice a day followed by a maintenance dose of 90 mg of olorofim twice a day.
Up until Protocol Amendment 06, 58 patients received a weight-based olorofim dosing consisting of a 1-day loading dose of 4 mg/kg/day on Day 1, then a maintenance dose of 2.5 mg/kg/day (divided into 2 or 3 doses). The dose was then adjusted based on plasma levels of olorofim with the maximum total daily dose of 300 mg.
|
|---|---|
|
Overall Study
STARTED
|
203
|
|
Overall Study
COMPLETED
|
126
|
|
Overall Study
NOT COMPLETED
|
77
|
Reasons for withdrawal
| Measure |
Olorofim (F901318)
Open-label single-arm of F901318 (olorofim) as treatment of invasive fungal infections due to Lomentospora prolificans, Scedosporium spp., Aspergillus spp., and other resistant fungi which are susceptible to F901318 in patients with limited treatment options.
Olorofim 30 mg tablets were given for up to 90 days in the Main Study Phase and could be continued for those entering the Extended Treatment Phase.
Patients received a 1-day loading dose of 150 mg of olorofim twice a day followed by a maintenance dose of 90 mg of olorofim twice a day.
Up until Protocol Amendment 06, 58 patients received a weight-based olorofim dosing consisting of a 1-day loading dose of 4 mg/kg/day on Day 1, then a maintenance dose of 2.5 mg/kg/day (divided into 2 or 3 doses). The dose was then adjusted based on plasma levels of olorofim with the maximum total daily dose of 300 mg.
|
|---|---|
|
Overall Study
Death in Main Phase
|
35
|
|
Overall Study
Lost to Follow up in Main Phase
|
1
|
|
Overall Study
Lost to follow up in Extended Phase
|
3
|
|
Overall Study
Clinically significant lab value in Main Phase
|
2
|
|
Overall Study
Clinically significant lab value in Extended Phase
|
4
|
|
Overall Study
Physician decision in Main Phase
|
1
|
|
Overall Study
Physician decision in Extended Phase
|
2
|
|
Overall Study
Death in Extended Phase
|
13
|
|
Overall Study
Intolerable adverse event in Main Phase
|
3
|
|
Overall Study
Intolerable adverse event in Extended Phase
|
1
|
|
Overall Study
Lack of compliance in Extended Phase
|
2
|
|
Overall Study
Treatment failure in Main Phase
|
2
|
|
Overall Study
Treatment failure in Extended Phase
|
4
|
|
Overall Study
Withdrawal of consent in Extended Phase
|
2
|
|
Overall Study
Other not specified reason in Main Phase
|
2
|
Baseline Characteristics
Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options
Baseline characteristics by cohort
| Measure |
Olorofim (F901318)
n=203 Participants
Open-label single-arm of Olorofim (F901318) as treatment of invasive fungal infections due to Lomentospora prolificans, Scedosporium spp., Aspergillus spp., and other resistant fungi which are susceptible to F901318 in patients with limited treatment options.
Olorofim 30 mg tablets were given for up to 90 days in the Main Study Phase and could be continued for those entering the Extended Treatment Phase.
Patients received fixed doses comprising of a 1-day loading dose of 150 mg of olorofim twice a day followed by a maintenance dose of 90 mg of olorofim twice a day.
Up until Protocol Amendment 06, 58 patients received a weight-based olorofim dosing consisting of a 1-day loading dose of 4 mg/kg/day on Day 1, then a maintenance dose of 2.5 mg/kg/day (divided into 2 or 3 doses). The dose was then adjusted based on plasma levels of olorofim with the maximum total daily dose of 300 mg.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
151 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
52 Participants
n=99 Participants
|
|
Age, Continuous
|
56.57 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
160 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
96 participants
n=99 Participants
|
|
Region of Enrollment
Egypt
|
1 participants
n=99 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=99 Participants
|
|
Region of Enrollment
Thailand
|
2 participants
n=99 Participants
|
|
Region of Enrollment
Spain
|
6 participants
n=99 Participants
|
|
Region of Enrollment
Russia
|
3 participants
n=99 Participants
|
|
Region of Enrollment
Netherlands
|
16 participants
n=99 Participants
|
|
Region of Enrollment
Belgium
|
45 participants
n=99 Participants
|
|
Region of Enrollment
Israel
|
8 participants
n=99 Participants
|
|
Region of Enrollment
Australia
|
18 participants
n=99 Participants
|
|
Region of Enrollment
Germany
|
5 participants
n=99 Participants
|
|
Body Mass Index
|
22.954 kg/m^2
n=99 Participants
|
|
Baseline Data Review Committee-Adjudicated Disease Category
Aspergillus - All
|
101 Participants
n=99 Participants
|
|
Baseline Data Review Committee-Adjudicated Disease Category
Lomentospora (Scedosporium) prolificans
|
26 Participants
n=99 Participants
|
|
Baseline Data Review Committee-Adjudicated Disease Category
Scedosporium spp.
|
22 Participants
n=99 Participants
|
|
Baseline Data Review Committee-Adjudicated Disease Category
Other Olorofim-susceptible fungi
|
12 Participants
n=99 Participants
|
|
Baseline Data Review Committee-Adjudicated Disease Category
Coccidioides
|
41 Participants
n=99 Participants
|
|
Baseline Data Review Committee-Adjudicated Disease Category
No DRC adjudicated baseline fungus
|
1 Participants
n=99 Participants
|
|
Reason for Limited Treatment Options
Known/predicted resistance to all licensed agents
|
42 Participants
n=99 Participants
|
|
Reason for Limited Treatment Options
Failure of available therapy
|
110 Participants
n=99 Participants
|
|
Reason for Limited Treatment Options
Intolerance to available therapy
|
29 Participants
n=99 Participants
|
|
Reason for Limited Treatment Options
Inability to manage drug interactions
|
7 Participants
n=99 Participants
|
|
Reason for Limited Treatment Options
Inability to produce therapeutic drug levels
|
2 Participants
n=99 Participants
|
|
Reason for Limited Treatment Options
IV only option produced clinical response and standard to switch to oral azole
|
10 Participants
n=99 Participants
|
|
Reason for Limited Treatment Options
Other, received Medical Monitor approval
|
2 Participants
n=99 Participants
|
|
Reason for Limited Treatment Options
Missing
|
1 Participants
n=99 Participants
|
|
Duration from Baseline Fungal Infection Start to First Treatment Administration
|
75.0 Days
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 42 in the Main Phase of study treatmentPopulation: The modified Intent to Treat (mITT) analysis set contains all participants in the ITT set who were assigned to a DRC-adjudicated disease category. The mITT population and subpopulations based on the DRC-adjudicated disease categories were used for the analysis of efficacy data.
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) criteria. For the primary statistical analysis of overall response rate, values were assigned to the DRC adjudicated overall response as follows: Success (Success-Complete, Success-Partial); Failure (Failure-Stable, Failure-Progression, Death, and participants for whom data at the Day 42 Study Visit could not be collected or participants who were considered not evaluable at the Day 42 Study Visit).
Outcome measures
| Measure |
Olorofim (F901318)
n=202 Participants
Single arm open label olorofim treatment.
|
|---|---|
|
Data Review Committee (DRC) Adjudicated Overall Response at Day 42
|
28.7 Response rate percentage
Interval 22.6 to 35.5
|
SECONDARY outcome
Timeframe: Day 42 in the Main Phase of study treatmentPopulation: The mITT subpopulation contains all participants in the ITT set who had a DRC-adjudicated baseline infection of All Aspergillus.
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline. The Aspergillus- All category is a combination of participants with Aspergillus proven and Aspergillus probable (invasive aspergillosis lower respiratory tract disease) baseline disease category. Overall success is defined as a Complete or Partial Response.
Outcome measures
| Measure |
Olorofim (F901318)
n=101 Participants
Single arm open label olorofim treatment.
|
|---|---|
|
DRC Adjudicated Overall Response at Day 42 for All Aspergillus
|
34.7 Response rate percentage
Interval 25.5 to 44.8
|
SECONDARY outcome
Timeframe: Day 42 in the Main Phase of study treatment Day 42 in the Main Phase of study treatment Day 42 in the Main Phase of study treatment Day 42 in the Main Phase of study treatment Day 42 in the Main Phase of study treatmentPopulation: The mITT subpopulation contains all participants in the ITT set who had a DRC-adjudicated baseline infection due to Lomentospora prolificans.
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent Data Review Committee using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline, this one is for participants with a proven infection due to Lomentospora prolificans. Success is defined as a Complete or Partial Response.
Outcome measures
| Measure |
Olorofim (F901318)
n=26 Participants
Single arm open label olorofim treatment.
|
|---|---|
|
DRC Adjudicated Overall Response at Day 42 for Lomentospora Prolificans
|
42.3 Response rate percentage
Interval 23.4 to 63.1
|
SECONDARY outcome
Timeframe: Day 42 in the Main Phase of study treatmentPopulation: The mITT subpopulation contains all participants in the ITT set who had a DRC-adjudicated baseline infection due to Scedosporium species.
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline, this one is for participants with a proven infection due to Scedosporium species. Success is defined as a Complete or Partial Response.
Outcome measures
| Measure |
Olorofim (F901318)
n=22 Participants
Single arm open label olorofim treatment.
|
|---|---|
|
DRC Adjudicated Overall Response at Day 42 for for Scedosporium Species
|
36.4 Response rate percentage
Interval 17.2 to 59.3
|
SECONDARY outcome
Timeframe: Day 42 in the Main Phase of study treatmentPopulation: The mITT subpopulation contains all participants in the ITT set who had a DRC-adjudicated baseline infection due to Coccidioides species.
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline, this one is for participants with proven infection due to Coccidioides species. Success is defined as a Complete or Partial Response.
Outcome measures
| Measure |
Olorofim (F901318)
n=41 Participants
Single arm open label olorofim treatment.
|
|---|---|
|
DRC Adjudicated Overall Response at Day 42 for Coccidioides Species
|
0.0 Response rate percentage
Interval 0.0 to 8.6
|
SECONDARY outcome
Timeframe: Day 42 in the Main Phase of study treatmentPopulation: The mITT subpopulation contains all participants in the ITT set who had a DRC-adjudicated baseline infection due to other olorofim susceptible fungi.
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline, this one is for participants with proven infection due to other olorofim susceptible fungi. Success is defined as a Complete or Partial Response.
Outcome measures
| Measure |
Olorofim (F901318)
n=12 Participants
Single arm open label olorofim treatment.
|
|---|---|
|
DRC Adjudicated Overall Response at Day 42 for Other Olorofim Susceptible Fungi
|
33.3 Response rate percentage
Interval 9.9 to 65.1
|
SECONDARY outcome
Timeframe: Day 84 in the Main Phase of study treatmentPopulation: The mITT set contains all participants in the ITT set who were assigned to a DRC-adjudicated disease category.
DRC-adjudicated overall response at Day 84, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on the EORTC/MSG criteria. For the analysis of overall response rate, values were assigned to the DRC-adjudicated overall response as follows: Success (Success-Complete, Success-Partial); Failure (Failure-Stable, Failure-Progression, Death, and participants for whom data at the Study Visit could not be collected or participants who were considered not evaluable at the Study Visit).
Outcome measures
| Measure |
Olorofim (F901318)
n=202 Participants
Single arm open label olorofim treatment.
|
|---|---|
|
DRC Adjudicated Overall Response at Day 84
|
27.2 Response rate percentage
Interval 21.2 to 33.9
|
SECONDARY outcome
Timeframe: Day 42 in the Main Phase of study treatmentPopulation: The mITT set contains all participants in the ITT set who were assigned to a DRC-adjudicated disease category.
Investigator-assessed overall response (as determined by the Investigator using all available assessment results including clinical, mycological and radiologic results based on the EORTC/MSG criteria) at Day 42, categorised by the same response criteria as in the primary endpoint: Success (Success-Complete, Success-Partial), Failure (Failure-Stable, Failure-Progression, Death, participants for whom data at Day 42 could not be collected or who were considered not evaluable at the specific visit).
Outcome measures
| Measure |
Olorofim (F901318)
n=202 Participants
Single arm open label olorofim treatment.
|
|---|---|
|
Investigator Assessed Overall Response at Day 42
|
24.8 Response rate percentage
Interval 19.0 to 31.3
|
SECONDARY outcome
Timeframe: Day 84 in the Main Phase of study treatmentPopulation: The mITT set contains all participants in the ITT set who were assigned to a DRC-adjudicated disease category.
Investigator-assessed overall response (as determined by the Investigator using all available assessment results including clinical, mycological and radiologic results based on the EORTC/MSG criteria) at Day 84, categorised by the same response criteria as in the primary endpoint: Success (Success-Complete, Success-Partial), Failure (Failure-Stable, Failure-Progression, Death, participants for whom data at Day 84 could not be collected or who were considered not evaluable at the specific visit).
Outcome measures
| Measure |
Olorofim (F901318)
n=202 Participants
Single arm open label olorofim treatment.
|
|---|---|
|
Investigator Assessed Overall Response at Day 84
|
29.7 Response rate percentage
Interval 23.5 to 36.5
|
SECONDARY outcome
Timeframe: Day 42 in the Main phase of study treatmentPopulation: The mITT set contains all participants in the ITT analysis set who were assigned to a DRC adjudicated disease category.
DRC adjudicated clinical response at the Day 42 Study Visit, as determined by an independent Data Review Committee using clinical response results based on EORTC/MSG criteria. Resolution is defined as a Complete or Partial Response.
Outcome measures
| Measure |
Olorofim (F901318)
n=202 Participants
Single arm open label olorofim treatment.
|
|---|---|
|
DRC Adjudicated Clinical Response at Day 42
|
59.9 Response rate percentage
Interval 52.8 to 66.7
|
SECONDARY outcome
Timeframe: Day 84 in the Main phase of study treatmentPopulation: The mITT set contains all participants in the ITT analysis set who were assigned to a DRC adjudicated disease category.
DRC adjudicated clinical response at the Day 84 Study Visit, as determined by an independent DRC using clinical response results based on EORTC/MSG criteria. Resolution is defined as a Complete or Partial Response.
Outcome measures
| Measure |
Olorofim (F901318)
n=202 Participants
Single arm open label olorofim treatment.
|
|---|---|
|
DRC Adjudicated Clinical Response at Day 84
|
54.0 Response rate percentage
Interval 46.8 to 61.0
|
SECONDARY outcome
Timeframe: Day 42 in the Main phase of study treatmentPopulation: The mITT set contains all patients in the ITT analysis set who were assigned to a DRC adjudicated disease category.
Investigator assessed clinical response at the Day 42 Study Visit using clinical response results based on the EORTC/MSG criteria. Resolution is defined as a Complete or Partial Response.
Outcome measures
| Measure |
Olorofim (F901318)
n=202 Participants
Single arm open label olorofim treatment.
|
|---|---|
|
Investigator Assessed Clinical Response at Day 42
|
53.5 Response rate percentage
Interval 46.3 to 60.5
|
SECONDARY outcome
Timeframe: Day 84 in the Main Phase of study treatmentPopulation: The mITT set contains all participants in the ITT analysis set who were assigned to a DRC adjudicated disease category.
Investigator assessed clinical response at the Day 84 Study Visit using clinical response results based on the EORTC/MSG criteria. Resolution is defined as a Complete or Partial Response.
Outcome measures
| Measure |
Olorofim (F901318)
n=202 Participants
Single arm open label olorofim treatment.
|
|---|---|
|
Investigator Assessed Clinical Response at Day 84
|
56.4 Response rate percentage
Interval 49.3 to 63.4
|
SECONDARY outcome
Timeframe: Day 42 in the Main Phase of study treatmentPopulation: The mITT set contains all participants in the ITT analysis set who were assigned to a DRC adjudicated disease category.
DRC adjudicated mycological response was assessed at the Day 42 Study Visit, as determined by an independent Data Review Committee using mycological response results based on EORTC/MSG criteria. Success is defined as eradication or presumed eradication.
Outcome measures
| Measure |
Olorofim (F901318)
n=202 Participants
Single arm open label olorofim treatment.
|
|---|---|
|
DRC Adjudicated Mycological Response at Day 42
|
18.3 Response rate percentage
Interval 13.1 to 24.4
|
SECONDARY outcome
Timeframe: Day 84 in the Main phase of study treatmentPopulation: The mITT set contains all participants in the ITT analysis set who were assigned to a DRC adjudicated disease category.
DRC adjudicated mycological response was assessed at the Day 84 Study Visit, as determined by an independent DRC using mycological response results based on EORTC/MSG criteria. Success is defined as eradication or presumed eradication.
Outcome measures
| Measure |
Olorofim (F901318)
n=202 Participants
Single arm open label olorofim treatment.
|
|---|---|
|
DRC Adjudicated Mycological Response at Day 84
|
22.5 Response rate percentage
Interval 16.9 to 28.9
|
SECONDARY outcome
Timeframe: Day 42 in the Main Phase of study treatmentPopulation: The mITT set contains all participants in the ITT analysis set who were assigned to a DRC adjudicated disease category.
Mycological response was assessed by the Investigator at the Day 42 Study Visit using mycological response results based on EORTC/MSG criteria. Success is defined as eradication or presumed eradication.
Outcome measures
| Measure |
Olorofim (F901318)
n=202 Participants
Single arm open label olorofim treatment.
|
|---|---|
|
Investigator Assessed Mycological Response at Day 42
|
25.7 Response rate percentage
Interval 19.9 to 32.3
|
SECONDARY outcome
Timeframe: Day 84 in the Main Phase of study treatmentPopulation: The mITT set contains all participants in the Intent to Treat analysis set who were assigned to a Data Review Committee adjudicated disease category.
Mycological response was assessed by the Investigator at the Day 84 Study Visit using mycological response results based on EORTC/MSG criteria. Success is defined as eradication or presumed eradication.
Outcome measures
| Measure |
Olorofim (F901318)
n=202 Participants
Single arm open label olorofim treatment.
|
|---|---|
|
Investigator Assessed Mycological Response at Day 84
|
31.7 Response rate percentage
Interval 25.3 to 38.6
|
SECONDARY outcome
Timeframe: Day 42 in the Main phase of study treatmentPopulation: The mITT set contains all participants in the ITT analysis set who were assigned to a DRC adjudicated disease category.
In participants for whom radiology formed a part of their diagnosis, radiology evaluations were required on Day 42 and were adjudicated by an independent DRC. Radiological responses were assigned as per EORTC/MSG criteria.
Outcome measures
| Measure |
Olorofim (F901318)
n=202 Participants
Single arm open label olorofim treatment.
|
|---|---|
|
DRC Adjudicated Radiological Response at Day 42
At least 90 percent improvement
|
11 Participants
|
|
DRC Adjudicated Radiological Response at Day 42
At least 50 to less than 90 percent improvement
|
10 Participants
|
|
DRC Adjudicated Radiological Response at Day 42
At least 25 to less than 50 percent improvement
|
12 Participants
|
|
DRC Adjudicated Radiological Response at Day 42
Stable findings (0 to less than 25 percent improvement)
|
55 Participants
|
|
DRC Adjudicated Radiological Response at Day 42
Worsening response
|
6 Participants
|
|
DRC Adjudicated Radiological Response at Day 42
No signs on Radiological images at Screening
|
7 Participants
|
|
DRC Adjudicated Radiological Response at Day 42
Not evaluable
|
75 Participants
|
|
DRC Adjudicated Radiological Response at Day 42
Not relevant
|
2 Participants
|
|
DRC Adjudicated Radiological Response at Day 42
Missing
|
0 Participants
|
|
DRC Adjudicated Radiological Response at Day 42
Death (from any cause)
|
24 Participants
|
SECONDARY outcome
Timeframe: Day 84 in the Main Phase of study treatmentPopulation: The mITT set contains all participants in the ITT analysis set who were assigned to a DRC adjudicated disease category.
In participants for whom radiology formed a part of their diagnosis, radiology evaluations were required on Day 84 and were adjudicated by an independent DRC. Radiological responses were assigned as per EORTC/MSG criteria.
Outcome measures
| Measure |
Olorofim (F901318)
n=202 Participants
Single arm open label olorofim treatment.
|
|---|---|
|
DRC Adjudicated Radiological Response at Day 84
At least 90 percent improvement
|
14 Participants
|
|
DRC Adjudicated Radiological Response at Day 84
At least 50 to less than 90 percent improvement
|
11 Participants
|
|
DRC Adjudicated Radiological Response at Day 84
At least 25 to less than 50 percent improvement
|
5 Participants
|
|
DRC Adjudicated Radiological Response at Day 84
Stable findings (0 to less than 25 percent improvement)
|
36 Participants
|
|
DRC Adjudicated Radiological Response at Day 84
Worsening response
|
6 Participants
|
|
DRC Adjudicated Radiological Response at Day 84
No signs on Radiological images at Screening
|
5 Participants
|
|
DRC Adjudicated Radiological Response at Day 84
Not evaluable
|
71 Participants
|
|
DRC Adjudicated Radiological Response at Day 84
Not relevant
|
2 Participants
|
|
DRC Adjudicated Radiological Response at Day 84
Missing
|
21 Participants
|
|
DRC Adjudicated Radiological Response at Day 84
Death (from any cause)
|
31 Participants
|
SECONDARY outcome
Timeframe: Day 42 in the Main Phase of study treatmentPopulation: The mITT set contains all participants in the ITT analysis set who were assigned to a DRC adjudicated disease category.
In participants for whom radiology formed a part of their diagnosis, radiology evaluations were required on Day 42. Radiological responses were assessed by the Investigator using EORTC/MSG criteria.
Outcome measures
| Measure |
Olorofim (F901318)
n=202 Participants
Single arm open label olorofim treatment.
|
|---|---|
|
Investigator Assessed Radiological Response at Day 42
At least 90 percent improvement
|
10 Participants
|
|
Investigator Assessed Radiological Response at Day 42
At least 50 to less than 90 percent improvement
|
20 Participants
|
|
Investigator Assessed Radiological Response at Day 42
At least 25 to less than 50 percent improvement
|
20 Participants
|
|
Investigator Assessed Radiological Response at Day 42
Stable findings (0 to less than 25 percent improvement)
|
29 Participants
|
|
Investigator Assessed Radiological Response at Day 42
Worsening response
|
11 Participants
|
|
Investigator Assessed Radiological Response at Day 42
No signs on Radiological images at Screening
|
3 Participants
|
|
Investigator Assessed Radiological Response at Day 42
Not evaluable
|
69 Participants
|
|
Investigator Assessed Radiological Response at Day 42
Missing
|
16 Participants
|
|
Investigator Assessed Radiological Response at Day 42
Death (from any cause)
|
24 Participants
|
SECONDARY outcome
Timeframe: Day 84 in the Main Phase of study treatmentPopulation: The mITT set contains all participants in the ITT analysis set who were assigned to a DRC adjudicated disease category.
In participants for whom radiology formed a part of their diagnosis, radiology evaluations were required on Day 84. Radiological responses were assessed by the Investigator using EORTC/MSG criteria.
Outcome measures
| Measure |
Olorofim (F901318)
n=202 Participants
Single arm open label olorofim treatment.
|
|---|---|
|
Investigator Assessed Radiological Response at Day 84
At least 90 percent improvement
|
23 Participants
|
|
Investigator Assessed Radiological Response at Day 84
At least 50 to less than 90 percent improvement
|
16 Participants
|
|
Investigator Assessed Radiological Response at Day 84
At least 25 to less than 50 percent improvement
|
16 Participants
|
|
Investigator Assessed Radiological Response at Day 84
Stable findings (0 to less than 25 percent improvement)
|
26 Participants
|
|
Investigator Assessed Radiological Response at Day 84
Worsening response
|
10 Participants
|
|
Investigator Assessed Radiological Response at Day 84
No signs on Radiological images at Screening
|
4 Participants
|
|
Investigator Assessed Radiological Response at Day 84
Not evaluable
|
52 Participants
|
|
Investigator Assessed Radiological Response at Day 84
Missing
|
24 Participants
|
|
Investigator Assessed Radiological Response at Day 84
Death (from any cause)
|
31 Participants
|
SECONDARY outcome
Timeframe: Day 42 in the Main Phase of study treatmentPopulation: The mITT set contains all patients in the Intent to Treat analysis set who were assigned to a DRC adjudicated disease category.
The all cause mortality rate at Day 42 uses the survival status that was entered at the study visit (which employs a window around each nominal study day).
Outcome measures
| Measure |
Olorofim (F901318)
n=202 Participants
Single arm open label olorofim treatment.
|
|---|---|
|
All Cause Mortality Rate at Day 42
|
11.9 Mortality rate percentage
Interval 7.8 to 17.2
|
SECONDARY outcome
Timeframe: Day 84 in the Main Phase of study treatmentPopulation: The mITT set contains all patients in the ITT analysis set who were assigned to a DRC adjudicated disease category.
The all cause mortality rate at Day 84 uses the survival status that was entered at the study visit (which employs a window around each nominal study day).
Outcome measures
| Measure |
Olorofim (F901318)
n=202 Participants
Single arm open label olorofim treatment.
|
|---|---|
|
All Cause Mortality Rate at Day 84
|
16.3 Mortality rate percentage
Interval 11.5 to 22.2
|
Adverse Events
Olorofim (F901318)
Serious events: 132 serious events
Other events: 186 other events
Deaths: 50 deaths
Serious adverse events
| Measure |
Olorofim (F901318)
n=203 participants at risk
Single arm open label olorofim treatment.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Abdominal sepsis
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Abscess limb
|
0.49%
1/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
3/203 • Number of events 3 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia refractory
|
1.5%
3/203 • Number of events 3 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.0%
4/203 • Number of events 4 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Vascular disorders
Aneurysm
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Renal and urinary disorders
Anuria
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Surgical and medical procedures
Apheresis
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Nervous system disorders
Arachnoid cyst
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Arthritis bacterial
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Arthritis fungal
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Arthritis infective
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Aspergillus infection
|
2.0%
4/203 • Number of events 4 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
3/203 • Number of events 3 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Bacteraemia
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Bacterial infection
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Blastic plasmacytoid dendritic cell neoplasia
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Investigations
Blood creatinine increased
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Surgical and medical procedures
Bone marrow transplant
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Brain abscess
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Bronchitis
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Candida infection
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Cardiac disorders
Cardiac arrest
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Cardiac disorders
Cardiac failure
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Cardiac disorders
Cardiac failure acute
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Catheter site infection
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Surgical and medical procedures
Cerebrospinal fluid reservoir placement
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
General disorders
Chest pain
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
CNS ventriculitis
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Coccidioidomycosis
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Injury, poisoning and procedural complications
Complications of transplanted lung
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Gastrointestinal disorders
Constipation
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
COVID-19
|
3.9%
8/203 • Number of events 8 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Vascular disorders
Deep vein thrombosis
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Product Issues
Device breakage
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Product Issues
Device leakage
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Product Issues
Device malfunction
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Device related infection
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Device related sepsis
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Disseminated aspergillosis
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Disseminated coccidioidomycosis
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Nervous system disorders
Dizziness postural
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
5/203 • Number of events 8 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Vascular disorders
Embolism
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Nervous system disorders
Encephalopathy
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Enterococcal infection
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Eye disorders
Exophthalmos
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Eye disorders
Eye pain
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Injury, poisoning and procedural complications
Fall
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
General disorders
Fatigue
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Fungal endocarditis
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Fungal infection
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Fungal skin infection
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Gastrointestinal disorders
Gastritis
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Gastroenteritis viral
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
General disorders
General physical health deterioration
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Immune system disorders
Graft versus host disease
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Immune system disorders
Graft versus host disease in lung
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.99%
2/203 • Number of events 4 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Nervous system disorders
Headache
|
1.5%
3/203 • Number of events 3 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Investigations
Hepatic enzyme increased
|
3.4%
7/203 • Number of events 10 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Surgical and medical procedures
Hospitalisation
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Nervous system disorders
Hydrocephalus
|
1.5%
3/203 • Number of events 3 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Vascular disorders
Hypotension
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Gastrointestinal disorders
Ileus
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
General disorders
Influenza like illness
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Intervertebral discitis
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Klebsiella sepsis
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Cardiac disorders
Left ventricular failure
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Nervous system disorders
Lethargy
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Investigations
Liver function test increased
|
3.4%
7/203 • Number of events 7 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal mass
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Nervous system disorders
Meningism
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Meningitis
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Meningitis coccidioides
|
2.5%
5/203 • Number of events 6 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Metapneumovirus infection
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Mycetoma mycotic
|
0.49%
1/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Mycobacterium chelonae infection
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloid leukaemia
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Gastrointestinal disorders
Nausea
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Nervous system disorders
Nervous system disorder
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
General disorders
Oedema peripheral
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Oral candidiasis
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Osteomyelitis
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Otitis externa
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Eye disorders
Papilloedema
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Cardiac disorders
Pericardial effusion
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Picornavirus infection
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Pneumonia
|
6.4%
13/203 • Number of events 13 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Pneumonia fungal
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Pneumonia viral
|
1.5%
3/203 • Number of events 3 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Postoperative wound infection
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Nervous system disorders
Presyncope
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Psoas abscess
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
3/203 • Number of events 3 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Pulmonary sepsis
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Purulent discharge
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
General disorders
Pyrexia
|
4.4%
9/203 • Number of events 11 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Renal abscess
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Renal and urinary disorders
Renal impairment
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.9%
8/203 • Number of events 8 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Respiratory tract infection
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Eye disorders
Retinal detachment
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Rhodococcus infection
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Nervous system disorders
Seizure
|
2.0%
4/203 • Number of events 5 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Sepsis
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Septic arthritis staphylococcal
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Septic shock
|
2.0%
4/203 • Number of events 5 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Cardiac disorders
Sinus bradycardia
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin squamous cell carcinoma recurrent
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Nervous system disorders
Somnolence
|
0.49%
1/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Nervous system disorders
Spinal cord compression
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Nervous system disorders
Status epilepticus
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Psychiatric disorders
Suicidal ideation
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Nervous system disorders
Syncope
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Nervous system disorders
Thalamic stroke
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Cardiac disorders
Toxic cardiomyopathy
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Investigations
Transaminases increased
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Eye disorders
Ulcerative keratitis
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Urinary tract infection
|
0.99%
2/203 • Number of events 3 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Urosepsis
|
0.99%
2/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Musculoskeletal and connective tissue disorders
Vertebral column mass
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Ear and labyrinth disorders
Vertigo
|
0.49%
1/203 • Number of events 2 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Gastrointestinal disorders
Vomiting
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Injury, poisoning and procedural complications
Wound
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Wound infection
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Wound sepsis
|
0.49%
1/203 • Number of events 1 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
Other adverse events
| Measure |
Olorofim (F901318)
n=203 participants at risk
Single arm open label olorofim treatment.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.4%
13/203 • Number of events 17 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Renal and urinary disorders
Acute kidney injury
|
7.4%
15/203 • Number of events 15 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
12/203 • Number of events 16 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.4%
15/203 • Number of events 23 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.9%
14/203 • Number of events 14 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Gastrointestinal disorders
Constipation
|
7.4%
15/203 • Number of events 17 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
19/203 • Number of events 19 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
COVID-19
|
8.9%
18/203 • Number of events 19 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.9%
14/203 • Number of events 14 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Psychiatric disorders
Depression
|
6.4%
13/203 • Number of events 13 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.7%
42/203 • Number of events 51 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.4%
15/203 • Number of events 17 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
General disorders
Fatigue
|
8.9%
18/203 • Number of events 19 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Nervous system disorders
Headache
|
15.8%
32/203 • Number of events 42 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Investigations
Hepatic enzyme increased
|
8.9%
18/203 • Number of events 22 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.4%
11/203 • Number of events 11 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Vascular disorders
Hypertension
|
5.4%
11/203 • Number of events 12 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.9%
16/203 • Number of events 22 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.9%
12/203 • Number of events 13 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Vascular disorders
Hypotension
|
7.9%
16/203 • Number of events 21 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Investigations
Liver function test increased
|
10.8%
22/203 • Number of events 27 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Gastrointestinal disorders
Nausea
|
19.7%
40/203 • Number of events 53 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
General disorders
Oedema peripheral
|
9.4%
19/203 • Number of events 21 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.4%
13/203 • Number of events 14 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
General disorders
Pyrexia
|
14.3%
29/203 • Number of events 41 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.4%
11/203 • Number of events 13 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Infections and infestations
Urinary tract infection
|
8.4%
17/203 • Number of events 24 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
|
Gastrointestinal disorders
Vomiting
|
19.7%
40/203 • Number of events 54 • Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).
Treatment emergent (TE) AEs occurring in main or extended phase are summarised here and defined as any AE which started or worsened on or after the first dose of main phase study treatment up to and including the post-treatment follow-up for the extended phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee F2G retains the right to review all articles referring to olorofim and generated from sponsored studies. All articles should be submitted to F2G for review at least 8 weeks prior to submission to the target journal. F2G reserves the right to delay publication or presentation if there is an issue relating to protecting intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER