Trial Outcomes & Findings for Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® Tablet In Korea (NCT NCT01073631)

Last Updated: 2012-06-07

Results Overview

Clinical response defined as: Cure=resolution of all baseline signs and symptoms of fungal infection(s); Improvement=lessening of baseline signs and symptoms or absence of one or more, but not all baseline findings; Failure=no improvement or deterioration of baseline condition; Unevaluable=incomplete therapy (efficacy could not be evaluated or discontinuation was not followed up).

Recruitment status

COMPLETED

Target enrollment

543 participants

Primary outcome timeframe

Baseline (Day 1) up to 2.1 Years

Results posted on

2012-06-07

Participant Flow

There were 543 participants enrolled in this study. Of these, 230 participants were treated with the Vfend tablet formulation only, and 313 participants were treated with Vfend tablet and Vfend intravenous (IV) formulations sequentially or vice versa. These 313 participants are also included in Study A1501067 (NCT01073618).

Participant milestones

Participant milestones
Measure	Vfend Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours \[loading dose\], 3 to 4mg/kg IV infusion every 12hours \[maintenance dose\]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
Overall Study STARTED	543
Overall Study COMPLETED	374
Overall Study NOT COMPLETED	169

Reasons for withdrawal

Reasons for withdrawal
Measure	Vfend Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours \[loading dose\], 3 to 4mg/kg IV infusion every 12hours \[maintenance dose\]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
Overall Study Death	82
Overall Study Adverse Event	24
Overall Study Other	63

Baseline Characteristics

Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® Tablet In Korea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vfend n=543 Participants Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours \[loading dose\], 3 to 4mg/kg IV infusion every 12hours \[maintenance dose\]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
Age, Customized <18 years	74 Participants n=99 Participants
Age, Customized Between 18 and 44 years	157 Participants n=99 Participants
Age, Customized Between 45 and 64 years	207 Participants n=99 Participants
Age, Customized >=65 years	105 Participants n=99 Participants
Sex: Female, Male Female	211 Participants n=99 Participants
Sex: Female, Male Male	332 Participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) up to 2.1 Years

Population: Safety population: participants received at least 1 dose of study drug for approved indication (= Intent to treat \[ITT\] population plus all unevaluable participants); ITT=participants received study drug for the approved indication and had been evaluated for related paramenters at least once.

Outcome measures

Outcome measures
Measure	Vfend n=543 Participants Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours \[loading dose\], 3 to 4mg/kg IV infusion every 12hours \[maintenance dose\]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable Cure	36.83 Percentage of participants
Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable Improvement	26.52 Percentage of participants
Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable Failure	16.94 Percentage of participants
Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable Unevaluable	19.71 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to 2.1 Years

Population: ITT; N=number of participants evaluated for mycological response.

In case cultivation performed, cultivated strain before and after Vfend administration recorded, and the improvement of mycological outcomes after administration evaluated. Mycological response defined as: Eradication=absence of signs and symptoms of fungal infection; Persistence=(no eradication) presence of fungal infection; Superinfection=existence of different strains from strains separated prior to study treatment; Not evaluable=a follow-up mycological cultivation not performed.

Outcome measures

Outcome measures
Measure	Vfend n=88 Participants Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours \[loading dose\], 3 to 4mg/kg IV infusion every 12hours \[maintenance dose\]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable Eradication	71.59 Percentage of participants
Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable Persistence	23.86 Percentage of participants
Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable Superinfection	2.27 Percentage of participants
Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable Not evaluable	2.27 Percentage of participants

Adverse Events

Vfend

Serious events: 119 serious events

Other events: 154 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vfend n=543 participants at risk Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours \[loading dose\], 3 to 4mg/kg IV infusion every 12hours \[maintenance dose\]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.55% 3/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Febrile neutropenia	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	0.55% 3/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombotic microangiopathy	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Arrhythmia	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Cardiac arrest	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Cardiac failure	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Cardiopulmonary failure	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Left ventricular dysfunction	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Supraventricular tachycardia	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Congenital, familial and genetic disorders Tracheo-oesophageal fistula	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Colitis	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastric perforation	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastric ulcer	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Neutropenic colitis	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Death	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Disease progression	0.55% 3/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Multi-organ failure	1.1% 6/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema peripheral	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	0.92% 5/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cholecystitis	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cholecystitis acute	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatitis	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Jaundice	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Immune system disorders Acute graft versus host disease in intestine	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Immune system disorders Acute graft versus host disease in skin	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Anal abscess	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Aspergillosis	0.74% 4/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Bronchitis	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Cytomegalovirus infection	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Enterococcal infection	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Fungal infection	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Infection	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Liver abscess	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	3.9% 21/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia staphylococcal	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pseudomembranous colitis	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Sepsis	2.8% 15/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Septic shock	3.3% 18/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Cytomegalovirus test positive	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Oxygen saturation decreased	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperkalaemia	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Metabolic acidosis	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.55% 3/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	2.2% 12/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Cerebellar infarction	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Cerebral haemorrhage	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Convulsion	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Grand mal convulsion	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Intracranial pressure increased	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Mental impairment	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Completed suicide	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Azotaemia	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Cystitis haemorrhagic	0.55% 3/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal failure acute	0.74% 4/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal impairment	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.1% 6/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.55% 3/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.55% 3/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.55% 3/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Haemorrhage	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Shock	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Endocrine disorders Euthyroid sick syndrome	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Erosive oesophagitis	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatic failure	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatic function abnormal	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatitis acute	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatotoxicity	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Cellulitis	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Central nervous system infection	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Citrobacter sepsis	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Cytomegalovirus chorioretinitis	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Device related infection	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia fungal	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Chemical peritonitis	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Acoustic stimulation tests	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dehydration	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Nephropathy toxic	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal failure	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal failure chronic	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Other adverse events
Measure	Vfend n=543 participants at risk Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours \[loading dose\], 3 to 4mg/kg IV infusion every 12hours \[maintenance dose\]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
Blood and lymphatic system disorders Anaemia	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Eosinophilia	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Febrile neutropenia	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Neutropenia	1.3% 7/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Pancytopenia	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	0.92% 5/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Atrial fibrillation	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Left ventricular dysfunction	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Tachycardia	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Otorrhoea	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Endocrine disorders Adrenal insufficiency	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Eye disorder	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Eye pain	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Keratoconjunctivitis sicca	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Ocular hyperaemia	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Vision blurred	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Visual acuity reduced	0.55% 3/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Visual impairment	1.1% 6/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	0.92% 5/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	0.92% 5/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastric ulcer	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastritis haemorrhagic	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Haematochezia	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Haemorrhoids	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Mouth haemorrhage	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	0.92% 5/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Oesophagitis	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Perianal erythema	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Reflux oesophagitis	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Stomatitis	0.74% 4/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	1.5% 8/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest discomfort	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Feeling abnormal	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Influenza like illness	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema peripheral	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pain	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	3.3% 18/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatic function abnormal	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatitis	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatitis toxic	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatotoxicity	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hyperbilirubinaemia	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Immune system disorders Acute graft versus host disease in intestine	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Immune system disorders Graft versus host disease	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Immune system disorders Hypersensitivity	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Anal abscess	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Appendicitis	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Cytomegalovirus viraemia	0.92% 5/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Herpes virus infection	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Herpes zoster	1.1% 6/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Infection	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Molluscum contagiosum	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Necrotising fasciitis	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Onychomycosis	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Oral herpes	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Orchitis	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Osteomyelitis	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	0.55% 3/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Sinusitis	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Staphylococcal bacteraemia	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tuberculosis	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase increased	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Aspartate aminotransferase increased	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood alkaline phosphatase	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood bilirubin increased	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood creatine increased	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood creatinine increased	0.74% 4/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood test	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood urea increased	0.74% 4/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Haemoglobin decreased	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Immunosuppressant drug level increased	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Liver function test abnormal	1.7% 9/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Neutrophil count decreased	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Platelet count decreased	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Transaminases increased	0.92% 5/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations White blood cell count decreased	0.55% 3/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations White blood cell count increased	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Diabetes mellitus	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperglycaemia	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperkalaemia	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypernatraemia	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypomagnesaemia	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyponatraemia	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscular weakness	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Ataxia	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Convulsion	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dysaesthesia	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dysarthria	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Neuropathy peripheral	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Peroneal nerve palsy	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Somnolence	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Tremor	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders VIIth nerve paralysis	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Delirium	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Depression	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Disorientation	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Insomnia	1.1% 6/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Major depression	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Cystitis haemorrhagic	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Dysuria	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Haematuria	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal failure acute	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.3% 7/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.74% 4/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dermatitis	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dermatitis contact	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Drug eruption	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Eczema asteatotic	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Ingrowing nail	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Petechiae	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Pruritus	0.92% 5/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	0.74% 4/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin lesion	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Urticaria	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Haemorrhage	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	0.37% 2/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypophagia	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Angina pectoris	0.18% 1/543 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER