Anidulafungin Plus Voriconazole Versus Voriconazole For T... | NCT00531479

NCT00531479

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Voriconazole	Active Comparator	Voriconazole monotherapy	Drug: voriconazole
Voriconazole and Anidulafungin	Experimental	Combination therapy with voriconazole and anidulafungin	Drug: anidulafungin Drug: voriconazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
voriconazole	Drug	First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV BID plus anidulafungin placebo IV qd. Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin placebo IV qd. Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin placebo IV qd, OR Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause Mortality at Week 6 in Participants With Proven or Probable Invasive Aspergillosis	Number of deaths measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.	Day 1 to Day 42 (Week 6)

Secondary Outcomes

Measure	Description	Time Frame
Global Response at Week 6	Number of participants with a successful response (complete or partial global response). Complete response = resolution of all clinical signs and symptoms and >90% of lesions due to IA that were visible on radiologic studies at baseline (BL); partial response = clinical improvement and >50% improvement in radiological findings present at BL.	Baseline, Day 42 (Week 6)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Birmingham	Alabama	35233	United States
Pfizer Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25599346	Derived	Marr KA, Schlamm HT, Herbrecht R, Rottinghaus ST, Bow EJ, Cornely OA, Heinz WJ, Jagannatha S, Koh LP, Kontoyiannis DP, Lee DG, Nucci M, Pappas PG, Slavin MA, Queiroz-Telles F, Selleslag D, Walsh TJ, Wingard JR, Maertens JA. Combination antifungal therapy for invasive aspergillosis: a randomized trial. Ann Intern Med. 2015 Jan 20;162(2):81-9. doi: 10.7326/M13-2508.
24914120

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Voriconazole/Anidulafungin	Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Voriconazole/Anidulafungin	Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
BG001	Voriconazole / Placebo	Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00026 OG00139

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	All-cause mortality calculated using the Kaplan-Meier (KM) product limit estimator on Day 42 (Week 6) within each stratum and weighted by the harmonic mean of the sample sizes in the strata. Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables were site of infection and host factors.	Z test for difference in proportions		0.0434	P-value based on a 1-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.	Mean Difference (Final Values)	-8.74			2-Sided	95	-18.99	1.51			The 95% CI was based on using Greenwood's formula for the variance of the KM estimator.	No

Secondary

Global Response at Week 6

Number of participants with a successful response (complete or partial global response). Complete response = resolution of all clinical signs and symptoms and >90% of lesions due to IA that were visible on radiologic studies at baseline (BL); partial response = clinical improvement and >50% improvement in radiological findings present at BL.

MITT; N = number of participants in MITT population at Week 6. Missing data and participants who died at Week 6 were treated as failure.

Posted

Number

participants

Baseline, Day 42 (Week 6)

ID	Title	Description
OG000	Voriconazole/Anidulafungin	Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
OG001	Voriconazole / Placebo	Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.

Secondary

All-cause Mortality at Week 6 in Participants With Possible, Probable, or Proven Invasive Aspergillosis (IA)

Number of deaths due to any cause measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.

Intent-to-treat (ITT) population: participants in MITT analysis set plus participants with possible IA who could not be upgraded to probable or proven IA within 7 days and had received at least 1 dose of study medication. N=number of participants in ITT population at Week 6.

Posted

Number

participants

Day 1 to Day 42 (Week 6)

ID	Title	Description
OG000	Voriconazole/Anidulafungin	Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
OG001	Voriconazole / Placebo	Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.

Secondary

All-cause Mortality at Week 12 in Participants With Probable or Proven Invasive Aspergillosis (IA)

Number of deaths due to any cause measured 12 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.

MITT; N=number of participants in MITT population at Week 12.

Posted

Number

participants

Day 1 to Day 84 (Week 12)

ID	Title	Description
OG000	Voriconazole/Anidulafungin	Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
OG001	Voriconazole / Placebo	Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.

Secondary

Mortality Due to Invasive Aspergillosis (IA) at Week 6 in Participants With Probable or Proven IA

Number of deaths due to Invasive Aspergillosis measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.

MITT; N = number of participants in MITT population at Week 6. Participants who died due to causes other than IA before Week 6 were censored at their time of death in this analysis.

Posted

Number

participants

Day 1 to Day 42 (Week 6)

ID	Title	Description
OG000	Voriconazole/Anidulafungin	Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
OG001	Voriconazole / Placebo	Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.

Secondary

Time to Death: All-Cause Mortality

Survival time from start of treatment. Time to death defined as date of death due to any cause minus first treatment date + 1.

MITT; N = number of participants in MITT population at time of assessment.

Posted

Median

Full Range

days

Day 1 to Day 84 (Week 12)

ID	Title	Description
OG000	Voriconazole/Anidulafungin	Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
OG001	Voriconazole / Placebo	Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.

Secondary

Time to Death Due to Invasive Aspergillosis (IA)

Survival time from start of treatment. Time to death defined as date of death due to IA minus first treatment date + 1.

MITT; N = number of participants in MITT population at time of assessment. Participants who died due to causes other than IA were defined as censored at time of death.

Posted

Median

Full Range

days

Day 1 to Day 84 (Week 12)

ID	Title	Description
OG000	Voriconazole/Anidulafungin	Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
OG001	Voriconazole / Placebo	Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Voriconazole/Anidulafungin	Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.			115	228	194	228
EG001	Voriconazole / Placebo	Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.			104	226	192	226

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected228 at risk EG0010 affected226 at risk
Blood disorder	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0012 affected226 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected228 at risk EG0016 affected226 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0013 affected226 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0013 affected226 at risk
Thrombotic microangiopathy	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected228 at risk EG0010 affected226 at risk
Arrhythmia	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected228 at risk EG0012 affected226 at risk
Bradycardia	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Cardiac arrest	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected228 at risk EG0011 affected226 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Extrasystoles	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Pericardial effusion	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0011 affected226 at risk
Tachycardia	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected228 at risk EG0012 affected226 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Blindness	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Blindness unilateral	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0011 affected226 at risk
Ascites	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0013 affected226 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0012 affected226 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Ileitis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Megacolon	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Neutropenic colitis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0011 affected226 at risk
Asthenia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0012 affected226 at risk
Chest pain	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Death	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Disease progression	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected228 at risk EG0011 affected226 at risk
Fatigue	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
General physical health deterioration	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0012 affected226 at risk
Multi-organ failure	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0005 affected228 at risk EG0014 affected226 at risk
Pyrexia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected228 at risk EG0014 affected226 at risk
Sudden cardiac death	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0012 affected226 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected228 at risk EG0010 affected226 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0011 affected226 at risk
Hepatic vein occlusion	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Graft versus host disease	Immune system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Aspergillosis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0006 affected228 at risk EG0015 affected226 at risk
Bacteraemia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0002 affected228 at risk EG0010 affected226 at risk
Bacterial sepsis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0011 affected226 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0011 affected226 at risk
Device related infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Disseminated tuberculosis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Endocarditis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Enterococcal sepsis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Escherichia sepsis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Fungal infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0011 affected226 at risk
Gastroenteritis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Genital herpes	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
H1N1 influenza	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Hepatic infection fungal	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Herpes zoster	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0002 affected228 at risk EG0010 affected226 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Lung abscess	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Lung infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Meningitis fungal	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Nocardiosis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Oral herpes	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Pneumocystis jiroveci pneumonia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Pneumonia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0005 affected228 at risk EG0015 affected226 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Sepsis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0009 affected228 at risk EG0017 affected226 at risk
Septic shock	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG00010 affected228 at risk EG00114 affected226 at risk
Sinusitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Sinusitis aspergillus	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Staphylococcal infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0012 affected226 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Systemic candida	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Tuberculosis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Zygomycosis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Complications of transplant surgery	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
C-reactive protein increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0011 affected226 at risk
Cytomegalovirus test positive	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Hepatic enzyme increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Lipase increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Liver function test abnormal	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0011 affected226 at risk
Oxygen saturation decreased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Procalcitonin increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Transaminases increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected228 at risk EG0010 affected226 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected228 at risk EG0010 affected226 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0011 affected226 at risk
Acute lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0012 affected226 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0006 affected228 at risk EG0014 affected226 at risk
B-cell lymphoma refractory	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Blast cell crisis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Central nervous system lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Chronic lymphocytic leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0002 affected228 at risk EG0010 affected226 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Leukaemia plasmacytic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0003 affected228 at risk EG0010 affected226 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0012 affected226 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Aphasia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Cerebral artery embolism	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected228 at risk EG0011 affected226 at risk
Cerebral infarction	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Convulsion	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected228 at risk EG0012 affected226 at risk
Dizziness	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Encephalopathy	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0012 affected226 at risk
Epilepsy	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Grand mal convulsion	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0011 affected226 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Loss of consciousness	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Petit mal epilepsy	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Toxic neuropathy	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Confusional state	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Hallucination	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Hallucination, visual	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Nephritic syndrome	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Oliguria	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0011 affected226 at risk
Renal failure	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected228 at risk EG0012 affected226 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0005 affected228 at risk EG0010 affected226 at risk
Renal impairment	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0011 affected226 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected228 at risk EG0014 affected226 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected228 at risk EG0011 affected226 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected228 at risk EG0014 affected226 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected228 at risk EG0013 affected226 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected228 at risk EG0010 affected226 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected228 at risk EG0013 affected226 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected228 at risk EG0012 affected226 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0012 affected226 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0011 affected226 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected228 at risk EG0010 affected226 at risk
Pulmonary infarction	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0012 affected226 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected228 at risk EG0010 affected226 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected228 at risk EG0016 affected226 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00011 affected228 at risk EG00114 affected226 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Aortic occlusion	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Haematoma	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Hypotension	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected228 at risk EG0011 affected226 at risk
Iliac artery thrombosis	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected226 at risk
Shock	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected226 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0007 affected228 at risk EG00113 affected226 at risk
Tachycardia	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG00012 affected228 at risk EG00119 affected226 at risk
Vision blurred	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG00014 affected228 at risk EG00111 affected226 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00014 affected228 at risk EG00112 affected226 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0009 affected228 at risk EG00115 affected226 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00035 affected228 at risk EG00130 affected226 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00039 affected228 at risk EG00137 affected226 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0006 affected228 at risk EG00112 affected226 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00038 affected228 at risk EG00142 affected226 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00032 affected228 at risk EG00123 affected226 at risk
Chest pain	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00016 affected228 at risk EG0019 affected226 at risk
Chills	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00013 affected228 at risk EG00110 affected226 at risk
Fatigue	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0005 affected228 at risk EG00114 affected226 at risk
Mucosal inflammation	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00010 affected228 at risk EG00115 affected226 at risk
Oedema	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00012 affected228 at risk EG00114 affected226 at risk
Oedema peripheral	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00034 affected228 at risk EG00134 affected226 at risk
Pain	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00010 affected228 at risk EG00113 affected226 at risk
Pyrexia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00028 affected228 at risk EG00142 affected226 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG00012 affected228 at risk EG0014 affected226 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG00012 affected228 at risk EG00113 affected226 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG00020 affected228 at risk EG0016 affected226 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG00015 affected228 at risk EG00114 affected226 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG00037 affected228 at risk EG00130 affected226 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG00018 affected228 at risk EG00115 affected226 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00013 affected228 at risk EG00112 affected226 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00016 affected228 at risk EG00111 affected226 at risk
Headache	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG00016 affected228 at risk EG00126 affected226 at risk
Agitation	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG00013 affected228 at risk EG0017 affected226 at risk
Anxiety	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG00012 affected228 at risk EG00115 affected226 at risk
Confusional state	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG00010 affected228 at risk EG00115 affected226 at risk
Hallucination, visual	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0007 affected228 at risk EG00112 affected226 at risk
Insomnia	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG00029 affected228 at risk EG00122 affected226 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00015 affected228 at risk EG00122 affected226 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00012 affected228 at risk EG00124 affected226 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00020 affected228 at risk EG00120 affected226 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0005 affected228 at risk EG00112 affected226 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00030 affected228 at risk EG00131 affected226 at risk
Hypertension	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG00032 affected228 at risk EG00121 affected226 at risk
Hypotension	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG00030 affected228 at risk EG00119 affected226 at risk

ID	Term
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D054714	Echinocandins
D010456	Peptides, Cyclic
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins