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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
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A study to evaluate olorofim (F901318) for the treatment of invasive fungal infections in participants lacking suitable alternative treatment options.
An open label, single arm Phase IIb study of olorofim (F901318) in participants with invasive fungal infections with limited treatment options. Participants received study treatment for up to 12 weeks in the main phase of the study. At the Investigator's request and after discussion with the medical monitor, open-label treatment with F901318 could be continued in patients judged by the Investigator to need therapy beyond 84 days and considered likely to continue to benefit from extended treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olorofim (F901318) | Experimental | Olorofim (F901318) was given orally for up to 90 days in the Main Study Phase and could be continued for those participants 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olorofim | Drug | 30mg oral tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Data Review Committee (DRC) Adjudicated Overall Response at Day 42 | 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). | Day 42 in the Main Phase of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| DRC Adjudicated Overall Response at Day 42 for 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Chen | Westmead Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley Fever Institute at Kern Medical Center | Bakersfield | California | 93306 | United States | ||
| UC Davis Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42008658 | Derived | Cornelissen K, Rex JH, Zinzi D, Law D, Upcott Gill R, Jones HM, Maertens J, Chen SC-A, Bruggemann R. Evaluation of the cytochrome P450-mediated drug interaction profile of olorofim. Antimicrob Agents Chemother. 2026 Jun 3;70(6):e0174525. doi: 10.1128/aac.01745-25. Epub 2026 Apr 20. | |
| 41914555 | Derived | Maertens J, Chen SCA, Thompson GR 3rd, Donovan F, Dane A, Birch M, Pinder C, Bennett J, Ravenna V, Marin Fernandez O, Ross G, Zinzi D, Rex JH; Phase 2b Olorofim Salvage Therapy Study Group. Olorofim in combination with azole antifungals: results from the Phase 2 salvage therapy study. J Antimicrob Chemother. 2026 Mar 4;81(4):dkag118. doi: 10.1093/jac/dkag118. |
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Individual participant data that underlie the results can be available to researchers after the primary publication of results for this study, after deidentification (text, tables, figures, appendices)
From 3 months after publication of the primary manuscript (no end date)
Requests should be directed to F2G for review.
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 28, 2020 | Jun 11, 2024 |
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| Day 42 in the Main Phase of study treatment |
| DRC Adjudicated Overall Response at Day 42 for 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. | 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 treatment |
| DRC Adjudicated Overall Response at Day 42 for for 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. | Day 42 in the Main Phase of study treatment |
| DRC Adjudicated Overall Response at Day 42 for 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. | Day 42 in the Main Phase of study treatment |
| DRC Adjudicated Overall Response at Day 42 for 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. | Day 42 in the Main Phase of study treatment |
| DRC Adjudicated Overall Response at Day 84 | 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). | Day 84 in the Main Phase of study treatment |
| Investigator Assessed Overall Response at Day 42 | 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). | Day 42 in the Main Phase of study treatment |
| Investigator Assessed Overall Response at Day 84 | 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). | Day 84 in the Main Phase of study treatment |
| DRC Adjudicated Clinical Response at Day 42 | 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. | Day 42 in the Main phase of study treatment |
| DRC Adjudicated Clinical Response at Day 84 | 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. | Day 84 in the Main phase of study treatment |
| Investigator Assessed Clinical Response at Day 42 | 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. | Day 42 in the Main phase of study treatment |
| Investigator Assessed Clinical Response at Day 84 | 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. | Day 84 in the Main Phase of study treatment |
| DRC Adjudicated Mycological Response at Day 42 | 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. | Day 42 in the Main Phase of study treatment |
| DRC Adjudicated Mycological Response at Day 84 | 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. | Day 84 in the Main phase of study treatment |
| Investigator Assessed Mycological Response at Day 42 | 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. | Day 42 in the Main Phase of study treatment |
| Investigator Assessed Mycological Response at Day 84 | 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. | Day 84 in the Main Phase of study treatment |
| DRC Adjudicated Radiological Response at Day 42 | 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. | Day 42 in the Main phase of study treatment |
| DRC Adjudicated Radiological Response at Day 84 | 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. | Day 84 in the Main Phase of study treatment |
| Investigator Assessed Radiological Response at Day 42 | 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. | Day 42 in the Main Phase of study treatment |
| Investigator Assessed Radiological Response at Day 84 | 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. | Day 84 in the Main Phase of study treatment |
| All Cause Mortality Rate at Day 42 | 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). | Day 42 in the Main Phase of study treatment |
| All Cause Mortality Rate at Day 84 | 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). | Day 84 in the Main Phase of study treatment |
| Sacramento |
| California |
| 95817 |
| United States |
| University of California San Diego Medical Center | San Diego | California | 92103 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794-0001 | United States |
| Duke University Health System | Durham | North Carolina | 27710 | United States |
| UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia |
| Peter MacCallum Centre-East Melbourne | Melbourne | Victoria | 3000 | Australia |
| Royal Melbourne Hospital | Melbourne | Victoria | 3000 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Fiona Stanley Hospital | Murdoch | Western Australia | 6150 | Australia |
| UZ Leuven | Leuven | Waals-Brabant | 3000 | Belgium |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| Hôpital Erasme | Brussels | 1070 | Belgium |
| Hospital FelÃcio Rocho | Belo Horizonte | Minas Gerais | 30110-934 | Brazil |
| Santa Casa de Misericórdia de Belo Horizonte | Belo Horizonte | Minas Gerais | 30150-221 | Brazil |
| HC - UFPR - Hospital de ClÃnicas da Universidade Federal do Paraná | Curitiba | Paraná | 80060-900 | Brazil |
| Santa Casa de Misericórdia de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Hospital de ClÃnicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Hospital São Lucas da PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Hospital da Universidade Federal de Santa Maria CEP/UFSM | Santa Maria | Rio Grande do Sul | 97105-900 | Brazil |
| Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer | Curitiba | 81520-060 | Brazil |
| Santa Casa de Misericórdia de Passos | Passos | 37904-020 | Brazil |
| Oncology Center, Mansoura University | Al Mansurah | 35516 | Egypt |
| Alexandria University Hospital | Alexandria | 21131 | Egypt |
| Cairo University Hospitals | Cairo | 11559 | Egypt |
| Ain Shams University Hospital | Cairo | 11566 | Egypt |
| Air Force Specialized Hospital | Cairo | 11566 | Egypt |
| National Cancer Institute | Cairo | 11796 | Egypt |
| Nasser Institute | Cairo | 12655 | Egypt |
| CHU Strasbourg - Hôpital Hautepierre | Strasbourg | Bas Rhin | 67091 | France |
| CHU de Grenoble - Hôpital Albert Michallon | Grenoble | Isere | 38043 | France |
| Hôpital Necker - Enfants Malades | Paris | Paris | 75015 | France |
| Hôpital Saint-Louis | Paris | 75475 | France |
| Klinikum der Universitaet Muenchen Campus Grosshadern | Munich | Bavaria | 81377 | Germany |
| Universitaetsklinikum Koeln | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin | Berlin | 12200 | Germany |
| Charite-Campus Benjamin Franklin (CBF) | Berlin | 12200 | Germany |
| Soroka University Medical Center | Beersheba | 84001 | Israel |
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
| Hadassah University Hospital - Ein Kerem | Jerusalem | 9112001 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 52363 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
| Radboudumc | Nijmegen | 6525 GA | Netherlands |
| Erasmus Medisch Centrum | Rotterdam | 3015 CE | Netherlands |
| UMC Utrecht | Utrecht | 3584 CX | Netherlands |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-214 | Poland |
| SPZOZ Szpital Uniwersytecki w Krakowie | Krakow | 31-501 | Poland |
| Wojewodzki Szpital Specjalistyczny im. J. Korczaka | SÅ‚upsk | 76-200 | Poland |
| Instytut Hematologii i Transfuzjologii | Warsaw | 02-776 | Poland |
| Leningrad Regional Clinical Hospital | Saint Petersburg | 194291 | Russia |
| FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov" | Saint Petersburg | Russia |
| Pavlov First Saint Petersburg State Medical University | Saint Petersburg | Russia |
| SBEIHPE "NWSMU n. a. I.I Mechnikov" of MoH and SD of RH | Saint Petersburg | Russia |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46021 | Spain |
| Siriraj Hospital | Bangkoknoi | Bangkok | 10700 | Thailand |
| King Chulalongkorn Memorial Hospital | Pathum Wan | Bangkok | 10330 | Thailand |
| Dicle University, Medical Faculty | Diyarbakır | 21280 | Turkey (Türkiye) |
| Acibadem Atakent Hospital | Istanbul | 34303 | Turkey (Türkiye) |
| Marmara University Pendik Research and Training Hospital | Istanbul | 34899 | Turkey (Türkiye) |
| King's College Hospital | London | Greater London | SE5 9NU | United Kingdom |
| Manchester Royal Infirmary | Manchester | Greater Manchester | M13 9WL | United Kingdom |
| Wythenshawe Hospital | Manchester | Wythenshawe | M23 9LT | United Kingdom |
| Bach Mai Hospital | Hanoi | 100000 | Vietnam |
| National Lung Hospital | Hanoi | 10000 | Vietnam |
| HCMC Hospital for Tropical Diseases | Ho Chi Minh City | 00000 | Vietnam |
| Blood Transfusion Hematology Hospital | Ho Chi Minh City | 0000 | Vietnam |
| 40541222 | Derived | Maertens JA, Thompson GR 3rd, Spec A, Donovan FM, Hammond SP, Bruns AHW, Rahav G, Shoham S, Johnson R, Rijnders B, Schaenman J, Hoenigl M, Morrissey CO, Mehta SR, Heath CH, Koehler P, Paterson DL, Slavin MA, Fortun J, Nguyen MH, Patterson TF, Uspenskaya O, Van de Veerdonk FL, Verweij PE, Aoun M, Georgala A, Alexander BD, Chayakulkeeree M, Mehra V, Miceli MH, Sikka MK, Sole A, Walsh TJ, Aguado JM, Holland SM, Moussa M, Rautemaa-Richardson R, Bazaz R, Schwartz S, Walsh SR, Plate M, Yehudai-Ofir D, Bruggemann RJ, Cornely OA, Ostrosky-Zeichner L, Vazquez JA, White PL, Cornelissen K, Ross GG, Fitton L, Dane A, Zinzi D, Rex JH, Chen SC. Olorofim for the treatment of invasive fungal diseases in patients with few or no therapeutic options: a single-arm, open-label, phase 2b study. Lancet Infect Dis. 2025 Nov;25(11):1177-1188. doi: 10.1016/S1473-3099(25)00224-5. Epub 2025 Jun 18. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Olorofim (F901318) | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Median | Full Range | kg/m^2 |
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| Baseline Data Review Committee-Adjudicated Disease Category | Count of Participants | Participants |
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| Reason for Limited Treatment Options | Count of Participants | Participants |
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| Duration from Baseline Fungal Infection Start to First Treatment Administration | Median | Full Range | Days |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Data Review Committee (DRC) Adjudicated Overall Response at Day 42 | 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). | 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. | Posted | Number | 95% Confidence Interval | Response rate percentage | Day 42 in the Main Phase of study treatment |
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| Secondary | DRC Adjudicated Overall Response at Day 42 for 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. | The mITT subpopulation contains all participants in the ITT set who had a DRC-adjudicated baseline infection of All Aspergillus. | Posted | Number | 95% Confidence Interval | Response rate percentage | Day 42 in the Main Phase of study treatment |
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| Secondary | DRC Adjudicated Overall Response at Day 42 for 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. | The mITT subpopulation contains all participants in the ITT set who had a DRC-adjudicated baseline infection due to Lomentospora prolificans. | Posted | Number | 95% Confidence Interval | Response rate percentage | 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 treatment |
|
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| Secondary | DRC Adjudicated Overall Response at Day 42 for for 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. | The mITT subpopulation contains all participants in the ITT set who had a DRC-adjudicated baseline infection due to Scedosporium species. | Posted | Number | 95% Confidence Interval | Response rate percentage | Day 42 in the Main Phase of study treatment |
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| Secondary | DRC Adjudicated Overall Response at Day 42 for 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. | The mITT subpopulation contains all participants in the ITT set who had a DRC-adjudicated baseline infection due to Coccidioides species. | Posted | Number | 95% Confidence Interval | Response rate percentage | Day 42 in the Main Phase of study treatment |
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| Secondary | DRC Adjudicated Overall Response at Day 42 for 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. | The mITT subpopulation contains all participants in the ITT set who had a DRC-adjudicated baseline infection due to other olorofim susceptible fungi. | Posted | Number | 95% Confidence Interval | Response rate percentage | Day 42 in the Main Phase of study treatment |
|
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| Secondary | DRC Adjudicated Overall Response at Day 84 | 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). | The mITT set contains all participants in the ITT set who were assigned to a DRC-adjudicated disease category. | Posted | Number | 95% Confidence Interval | Response rate percentage | Day 84 in the Main Phase of study treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Investigator Assessed Overall Response at Day 42 | 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). | The mITT set contains all participants in the ITT set who were assigned to a DRC-adjudicated disease category. | Posted | Number | 95% Confidence Interval | Response rate percentage | Day 42 in the Main Phase of study treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Investigator Assessed Overall Response at Day 84 | 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). | The mITT set contains all participants in the ITT set who were assigned to a DRC-adjudicated disease category. | Posted | Number | 95% Confidence Interval | Response rate percentage | Day 84 in the Main Phase of study treatment |
|
| ||||||||||||||||||||||||||
| Secondary | DRC Adjudicated Clinical Response at Day 42 | 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. | The mITT set contains all participants in the ITT analysis set who were assigned to a DRC adjudicated disease category. | Posted | Number | 95% Confidence Interval | Response rate percentage | Day 42 in the Main phase of study treatment |
|
| ||||||||||||||||||||||||||
| Secondary | DRC Adjudicated Clinical Response at Day 84 | 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. | The mITT set contains all participants in the ITT analysis set who were assigned to a DRC adjudicated disease category. | Posted | Number | 95% Confidence Interval | Response rate percentage | Day 84 in the Main phase of study treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Investigator Assessed Clinical Response at Day 42 | 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. | The mITT set contains all patients in the ITT analysis set who were assigned to a DRC adjudicated disease category. | Posted | Number | 95% Confidence Interval | Response rate percentage | Day 42 in the Main phase of study treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Investigator Assessed Clinical Response at Day 84 | 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. | The mITT set contains all participants in the ITT analysis set who were assigned to a DRC adjudicated disease category. | Posted | Number | 95% Confidence Interval | Response rate percentage | Day 84 in the Main Phase of study treatment |
|
| ||||||||||||||||||||||||||
| Secondary | DRC Adjudicated Mycological Response at Day 42 | 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. | The mITT set contains all participants in the ITT analysis set who were assigned to a DRC adjudicated disease category. | Posted | Number | 95% Confidence Interval | Response rate percentage | Day 42 in the Main Phase of study treatment |
|
| ||||||||||||||||||||||||||
| Secondary | DRC Adjudicated Mycological Response at Day 84 | 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. | The mITT set contains all participants in the ITT analysis set who were assigned to a DRC adjudicated disease category. | Posted | Number | 95% Confidence Interval | Response rate percentage | Day 84 in the Main phase of study treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Investigator Assessed Mycological Response at Day 42 | 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. | The mITT set contains all participants in the ITT analysis set who were assigned to a DRC adjudicated disease category. | Posted | Number | 95% Confidence Interval | Response rate percentage | Day 42 in the Main Phase of study treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Investigator Assessed Mycological Response at Day 84 | 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. | The mITT set contains all participants in the Intent to Treat analysis set who were assigned to a Data Review Committee adjudicated disease category. | Posted | Number | 95% Confidence Interval | Response rate percentage | Day 84 in the Main Phase of study treatment |
|
| ||||||||||||||||||||||||||
| Secondary | DRC Adjudicated Radiological Response at Day 42 | 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. | The mITT set contains all participants in the ITT analysis set who were assigned to a DRC adjudicated disease category. | Posted | Count of Participants | Participants | No | Day 42 in the Main phase of study treatment |
|
| ||||||||||||||||||||||||||
| Secondary | DRC Adjudicated Radiological Response at Day 84 | 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. | The mITT set contains all participants in the ITT analysis set who were assigned to a DRC adjudicated disease category. | Posted | Count of Participants | Participants | No | Day 84 in the Main Phase of study treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Investigator Assessed Radiological Response at Day 42 | 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. | The mITT set contains all participants in the ITT analysis set who were assigned to a DRC adjudicated disease category. | Posted | Count of Participants | Participants | No | Day 42 in the Main Phase of study treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Investigator Assessed Radiological Response at Day 84 | 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. | The mITT set contains all participants in the ITT analysis set who were assigned to a DRC adjudicated disease category. | Posted | Count of Participants | Participants | No | Day 84 in the Main Phase of study treatment |
|
| ||||||||||||||||||||||||||
| Secondary | All Cause Mortality Rate at Day 42 | 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). | The mITT set contains all patients in the Intent to Treat analysis set who were assigned to a DRC adjudicated disease category. | Posted | Number | 95% Confidence Interval | Mortality rate percentage | Day 42 in the Main Phase of study treatment |
|
| ||||||||||||||||||||||||||
| Secondary | All Cause Mortality Rate at Day 84 | 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). | The mITT set contains all patients in the ITT analysis set who were assigned to a DRC adjudicated disease category. | Posted | Number | 95% Confidence Interval | Mortality rate percentage | Day 84 in the Main Phase of study treatment |
|
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Olorofim (F901318) | Single arm open label olorofim treatment. | 50 | 203 | 132 | 203 | 186 | 203 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Acute febrile neutrophilic dermatosis | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Acute myeloid leukaemia refractory | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Aneurysm | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Anuria | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Apheresis | Surgical and medical procedures | MedDRA (25.1) | Systematic Assessment |
| |
| Arachnoid cyst | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Arthritis fungal | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Blastic plasmacytoid dendritic cell neoplasia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Bone marrow transplant | Surgical and medical procedures | MedDRA (25.1) | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cerebrospinal fluid reservoir placement | Surgical and medical procedures | MedDRA (25.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| CNS ventriculitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Coccidioidomycosis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Complications of transplanted lung | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Device breakage | Product Issues | MedDRA (25.1) | Systematic Assessment |
| |
| Device leakage | Product Issues | MedDRA (25.1) | Systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA (25.1) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Disseminated aspergillosis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Disseminated coccidioidomycosis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Exophthalmos | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Fungal endocarditis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Gastroenteritis bacterial | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Graft versus host disease in lung | Immune system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Hospitalisation | Surgical and medical procedures | MedDRA (25.1) | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Intraventricular haemorrhage | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Mediastinal mass | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Meningism | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Meningitis coccidioides | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Metapneumovirus infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Mycetoma mycotic | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Mycobacterium chelonae infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Papilloedema | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Picornavirus infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Post transplant lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pseudomeningocele | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Psoas abscess | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pulseless electrical activity | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Purulent discharge | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Renal abscess | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Respiratory tract infection bacterial | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rhodococcus infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Septic arthritis staphylococcal | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Shunt malfunction | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Skin squamous cell carcinoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| T-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Thalamic stroke | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Toxic cardiomyopathy | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Ulcerative keratitis | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Vertebral column mass | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Wound sepsis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniela Zinzi | F2G Ltd | 43 664 3582281 | dzinzi@f2g.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 6, 2023 | Jun 11, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| D003047 | Coccidioidomycosis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000626907 | olorofim |
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United Kingdom |
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| Thailand |
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| Spain |
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| Russia |
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| Netherlands |
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| Belgium |
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| Israel |
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| Australia |
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| Germany |
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| Scedosporium spp. |
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| Other Olorofim-susceptible fungi |
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| Coccidioides |
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| No DRC adjudicated baseline fungus |
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| Intolerance to available therapy |
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| Inability to manage drug interactions |
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| Inability to produce therapeutic drug levels |
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| IV only option produced clinical response and standard to switch to oral azole |
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| Other, received Medical Monitor approval |
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| Missing |
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