Panobinostat or Placebo With Bortezomib and Dexamethasone... | NCT01023308

ID	Type	Description	Link
2009-015507-52	EudraCT Number

Label	Type	Description	Intervention Names
Panobinostat + Bortezomib + Dexamethasone	Experimental		Drug: Panobinostat Drug: Bortezomib Drug: Dexamethasone
Placebo + Bortezomib + Dexamethasone	Placebo Comparator		Drug: Bortezomib Drug: Dexamethasone Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Panobinostat	Drug	Panobinostat was administered 3x week ( 2 weeks on 1 week off)	Panobinostat + Bortezomib + Dexamethasone

Measure	Description	Time Frame
Progression-free Survival Events in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.		45 months
Progression Free Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.		45 months

Measure	Description	Time Frame
Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone	Number of OS events	45 months
Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Phoenix	Arizona		United States
Novartis Investigative Site

PubMed Identifier	Type	Citation	Retractions
27751707	Derived	San-Miguel JF, Hungria VT, Yoon SS, Beksac M, Dimopoulos MA, Elghandour A, Jedrzejczak WW, Gunther A, Nakorn TN, Siritanaratkul N, Schlossman RL, Hou J, Moreau P, Lonial S, Lee JH, Einsele H, Sopala M, Bengoudifa BR, Binlich F, Richardson PG. Overall survival of patients with relapsed multiple myeloma treated with panobinostat or placebo plus bortezomib and dexamethasone (the PANORAMA 1 trial): a randomised, placebo-controlled, phase 3 trial. Lancet Haematol. 2016 Nov;3(11):e506-e515. doi: 10.1016/S2352-3026(16)30147-8. Epub 2016 Oct 14.
27677481

Label	URL
Related Info	View source

ID	Title	Description
FG000	Panobinostat + Bortezomib	Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
FG001	Placebo + Bortezomib

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression-free Survival Events in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Posted

Number

number of events

45 months

ID	Title	Description
OG000	Panobinostat + Bortezomib	Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
OG001	Placebo + Bortezomib	Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.

Units	Counts
Participants	OG000387 OG001381

Title

Denominators

Categories

Title	Measurements
	OG000207 OG001260

Primary

Progression Free Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Full Analysis Set

Posted

Median

95% Confidence Interval

months

45 months

ID	Title	Description
OG000	Panobinostat + Bortezomib	Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
OG001	Placebo + Bortezomib	Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.

Units	Counts
Participants	OG000

Secondary

Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone

Number of OS events

Posted

Number

Number of OS events

45 months

ID	Title	Description
OG000	Panobinostat + Bortezomib	Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
OG001	Placebo + Bortezomib	Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.

Units	Counts
Participants	OG000

Secondary

Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone

survival time in months

FAS

Posted

Median

95% Confidence Interval

months

45 months

ID	Title	Description
OG000	Panobinostat + Bortezomib	Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
OG001	Placebo + Bortezomib	Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.

Units	Counts
Participants	OG000

Secondary

Overall Response Rate in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Best overall response based on mEBMT criteria per investigator assessment

Posted

Number

% participants with response

45 months

ID	Title	Description
OG000	Panobinostat + Bortezomib	Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
OG001	Placebo + Bortezomib	Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.

Units	Counts
Participants	OG000

Secondary

Time to Response Per Investigator Assessment (mEBMT Criteria) of Response Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Posted

Median

95% Confidence Interval

time to response in months

45 months

ID	Title	Description
OG000	Panobinostat + Bortezomib	Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
OG001	Placebo + Bortezomib	Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.

Units	Counts
Participants	OG000

Secondary

Duration of Response Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Posted

Median

95% Confidence Interval

duration of response in months

45 months

ID	Title	Description
OG000	Panobinostat + Bortezomib	Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
OG001	Placebo + Bortezomib	Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.

Units	Counts
Participants	OG000

Secondary

Time to Progression/Relapse Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Posted

Median

95% Confidence Interval

months

45 months

ID	Title	Description
OG000	Panobinostat + Bortezomib	Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
OG001	Placebo + Bortezomib	Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.

Units	Counts
Participants	OG000

Secondary

European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group

Higher values in the disease symptoms and side effects of treatment scores indicate worsening. Higher scores in the future perspective and body image scores indicate improvement. LS Means and SEM are estimated from the repeated measures model. Following factors and covariates are included in the repeated measurement model: time, treatment, treatment by time interaction, number of prior lines of anti-MM therapy (1/ 2 and 3), prior use of BTZ (Yes/ No), baseline score.Disease Symptom is the sum of 20 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome)", All subscales of EORTC QLQ-MY20 have the same score range of 0 -100. Decrease in symptom scores from baseline indicate improvement in symptoms.

Full Analysis Set

Posted

Least Squares Mean

95% Confidence Interval

score on a scale

12, 24 and 48 weeks

ID	Title	Description
OG000	Panobinostat + Bortezomib	Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
OG001	Placebo + Bortezomib	Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.

Secondary

European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group

The EORTC QLQ-C30 measures functional dimensions (physical, role, emotional, cognitive, and social), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), six single-item symptom scales (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale. Disease Symptom is the sum of 30 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome)", All subscales of EORTC QLQ-C30 have the same score range of 0 -100. For global health status and other functional scales,an increase from baseline indicates improvement of QoL. Whereas for symptoms scales, fatigue, dyspnea, insomnia, appetite loss, constipation and diarrhea, decrease in scores from baseline indicate improvement in symptoms.

Full Analysis Set

Posted

Least Squares Mean

95% Confidence Interval

score on a scale

12, 24 and 48 weeks

ID	Title	Description
OG000	Panobinostat + Bortezomib	Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
OG001	Placebo + Bortezomib	Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.

Secondary

Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group

Chronic Illness Therapy (FACIT) Measurement System and focuses on four general quality of life domains for physical well being, functional well-being, social/family well-being, and emotional well-being, and includes additional items to characterize treatment-related neurotoxicity. Higher subscales/total scores represent higher QOL. In the case of the neurotoxicity subscale, lower scores correspond to higher neurotoxicity. The recall period referenced in the questionnaire is the past 7 days.Ranges for FACT-G subscales are as follows:.PWB, scale 0 -28, , NtxS scale 0-44, FACT/GOG-Ntx trial outcome index scale is 0-100 and FACT-G scale is also scaled 0-100. An increase from baseline in these scores indicate improvement.

Full Analysis Set

Posted

Least Squares Mean

95% Confidence Interval

score on a scale

12, 24 and 48 weeks

ID	Title	Description
OG000	Panobinostat + Bortezomib	Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
OG001	Placebo + Bortezomib	Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00014 affected381 at risk EG0013 affected377 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0003 affected381 at risk EG0011 affected377 at risk
Hyperviscosity syndrome	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0010 affected377 at risk
Monocytosis	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0011 affected377 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00028 affected381 at risk EG0018 affected377 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Angina pectoris	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0012 affected377 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0004 affected381 at risk EG0012 affected377 at risk
Atrial flutter	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Bradycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0010 affected377 at risk
Cardiac arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0012 affected377 at risk
Cardiac failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Cardiac failure acute	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0010 affected377 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0010 affected377 at risk
Pericardial effusion	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Sinus tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0010 affected377 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Vertigo	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Conjunctivitis	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Exophthalmos	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected381 at risk EG0013 affected377 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Colitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected381 at risk EG0010 affected377 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected381 at risk EG0013 affected377 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00043 affected381 at risk EG0019 affected377 at risk
Dysphagia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Faecaloma	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0010 affected377 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0010 affected377 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0013 affected377 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Haematemesis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Haematochezia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0010 affected377 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Ileus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0005 affected381 at risk EG0013 affected377 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0011 affected377 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0007 affected381 at risk EG0010 affected377 at risk
Necrotising oesophagitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0011 affected377 at risk
Peritoneal necrosis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Subileus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0010 affected377 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00012 affected381 at risk EG0013 affected377 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG00015 affected381 at risk EG0016 affected377 at risk
Chest discomfort	General disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Chills	General disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG00011 affected381 at risk EG0012 affected377 at risk
General physical health deterioration	General disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0010 affected377 at risk
Generalised oedema	General disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Hypothermia	General disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0012 affected377 at risk
Multi-organ failure	General disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0013 affected377 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG00016 affected381 at risk EG00111 affected377 at risk
Spinal pain	General disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Sudden death	General disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Biliary dyskinesia	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Jaundice	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Acute tonsillitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Appendicitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Aspergillosis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Atypical pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Bacteraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Bacteriuria	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected381 at risk EG0012 affected377 at risk
Bronchopneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0011 affected377 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0010 affected377 at risk
Cytomegalovirus colitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Device related infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Device related sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Disseminated tuberculosis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Diverticulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Enteritis infectious	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Erysipelas	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0007 affected381 at risk EG0012 affected377 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0010 affected377 at risk
Gastrointestinal infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Haemophilus sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Hepatitis B	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected381 at risk EG0011 affected377 at risk
Herpes zoster	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected381 at risk EG0015 affected377 at risk
Infection	Infections and infestations	MedDRA	Systematic Assessment	EG0005 affected381 at risk EG0012 affected377 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Lobar pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0010 affected377 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected381 at risk EG0013 affected377 at risk
Lung infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0012 affected377 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Necrotising fasciitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0012 affected377 at risk
Neutropenic sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0011 affected377 at risk
Oral candidiasis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Parotitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Periodontitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Pharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0011 affected377 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG00056 affected381 at risk EG00140 affected377 at risk
Pneumonia bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0012 affected377 at risk
Pneumonia fungal	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0010 affected377 at risk
Pneumonia haemophilus	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Pneumonia influenzal	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0011 affected377 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected381 at risk EG0012 affected377 at risk
Salmonellosis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0009 affected381 at risk EG0017 affected377 at risk
Septic shock	Infections and infestations	MedDRA	Systematic Assessment	EG0009 affected381 at risk EG0012 affected377 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Skin infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Streptococcal sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected381 at risk EG0013 affected377 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0008 affected381 at risk EG0014 affected377 at risk
Varicella	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Viral haemorrhagic cystitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Viral infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0010 affected377 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 affected381 at risk EG0010 affected377 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Alanine aminotransferase increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Aspartate aminotransferase increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Blood creatinine increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0012 affected377 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Blood potassium decreased	Investigations	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Blood pressure decreased	Investigations	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
C-reactive protein increased	Investigations	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0010 affected377 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0012 affected377 at risk
General physical condition abnormal	Investigations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Platelet count decreased	Investigations	MedDRA	Systematic Assessment	EG0004 affected381 at risk EG0010 affected377 at risk
Weight decreased	Investigations	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
White blood cell count decreased	Investigations	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0004 affected381 at risk EG0012 affected377 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00011 affected381 at risk EG0015 affected377 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0013 affected377 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0013 affected377 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Hypochloraemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0012 affected377 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0008 affected381 at risk EG0014 affected377 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0004 affected381 at risk EG0011 affected377 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0010 affected377 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0010 affected377 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected381 at risk EG0012 affected377 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0010 affected377 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0012 affected377 at risk
Altered state of consciousness	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Autonomic neuropathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Brain compression	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Brain injury	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Brain oedema	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Central nervous system haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Central nervous system necrosis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0012 affected377 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 affected381 at risk EG0010 affected377 at risk
Coma	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Convulsion	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Cranial nerve paralysis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0005 affected381 at risk EG0012 affected377 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Hemiparesis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Hyperreflexia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Lacunar infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Loss of consciousness	Nervous system disorders	MedDRA	Systematic Assessment	EG0005 affected381 at risk EG0011 affected377 at risk
Neuralgia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 affected381 at risk EG0011 affected377 at risk
Paraparesis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Paraplegia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Polyneuropathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Sciatica	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Sensory loss	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Somnolence	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Speech disorder	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0005 affected381 at risk EG0012 affected377 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Confusional state	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Delirium	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Hypomania	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Mental disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Mental status changes	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Anuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Azotaemia	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Oliguria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Renal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0004 affected381 at risk EG0014 affected377 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0007 affected381 at risk EG0019 affected377 at risk
Renal impairment	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0012 affected377 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 affected381 at risk EG0011 affected377 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 affected381 at risk EG0017 affected377 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0011 affected377 at risk
Hypoventilation	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 affected381 at risk EG0010 affected377 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0013 affected377 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 affected381 at risk EG0014 affected377 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0005 affected381 at risk EG0010 affected377 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Acute febrile neutrophilic dermatosis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0011 affected377 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Aortic stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Circulatory collapse	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0010 affected377 at risk
Deep vein thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected381 at risk EG0013 affected377 at risk
Embolism	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Haematoma	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0005 affected381 at risk EG0012 affected377 at risk
Hypovolaemic shock	Vascular disorders	MedDRA	Systematic Assessment	EG0003 affected381 at risk EG0010 affected377 at risk
Lymphoedema	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected381 at risk EG0011 affected377 at risk
Orthostatic hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0009 affected381 at risk EG0011 affected377 at risk
Shock haemorrhagic	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0010 affected377 at risk
Venous thrombosis limb	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected381 at risk EG0011 affected377 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG000154 affected381 at risk EG001125 affected377 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00061 affected381 at risk EG00131 affected377 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00052 affected381 at risk EG00135 affected377 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG000112 affected381 at risk EG00140 affected377 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG000238 affected381 at risk EG001150 affected377 at risk
Conjunctivitis	Eye disorders	MedDRA	Systematic Assessment	EG00028 affected381 at risk EG00131 affected377 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00030 affected381 at risk EG00125 affected377 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00050 affected381 at risk EG00138 affected377 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00043 affected381 at risk EG00136 affected377 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG000101 affected381 at risk EG001122 affected377 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG000254 affected381 at risk EG001155 affected377 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00047 affected381 at risk EG00143 affected377 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG000137 affected381 at risk EG00178 affected377 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00091 affected381 at risk EG00147 affected377 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG00077 affected381 at risk EG00151 affected377 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG000155 affected381 at risk EG001109 affected377 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG000108 affected381 at risk EG00172 affected377 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG00090 affected381 at risk EG00148 affected377 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG00020 affected381 at risk EG00125 affected377 at risk
Herpes zoster	Infections and infestations	MedDRA	Systematic Assessment	EG00015 affected381 at risk EG00136 affected377 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00049 affected381 at risk EG00146 affected377 at risk
Respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00017 affected381 at risk EG00120 affected377 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00065 affected381 at risk EG00153 affected377 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00023 affected381 at risk EG00115 affected377 at risk
Alanine aminotransferase increased	Investigations	MedDRA	Systematic Assessment	EG00022 affected381 at risk EG00119 affected377 at risk
Blood creatinine increased	Investigations	MedDRA	Systematic Assessment	EG00037 affected381 at risk EG00121 affected377 at risk
Blood urea increased	Investigations	MedDRA	Systematic Assessment	EG00020 affected381 at risk EG00110 affected377 at risk
Platelet count decreased	Investigations	MedDRA	Systematic Assessment	EG00043 affected381 at risk EG00117 affected377 at risk
Weight decreased	Investigations	MedDRA	Systematic Assessment	EG00044 affected381 at risk EG00117 affected377 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG000106 affected381 at risk EG00146 affected377 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00030 affected381 at risk EG00125 affected377 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00021 affected381 at risk EG0018 affected377 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00035 affected381 at risk EG00132 affected377 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG000100 affected381 at risk EG00152 affected377 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00048 affected381 at risk EG00118 affected377 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00042 affected381 at risk EG00132 affected377 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00025 affected381 at risk EG00126 affected377 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00045 affected381 at risk EG00146 affected377 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00021 affected381 at risk EG00131 affected377 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00023 affected381 at risk EG00121 affected377 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00024 affected381 at risk EG00120 affected377 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00024 affected381 at risk EG00124 affected377 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00040 affected381 at risk EG00154 affected377 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG00067 affected381 at risk EG00161 affected377 at risk
Dysgeusia	Nervous system disorders	MedDRA	Systematic Assessment	EG00036 affected381 at risk EG00126 affected377 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG00051 affected381 at risk EG00140 affected377 at risk
Hypoaesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG00028 affected381 at risk EG00134 affected377 at risk
Neuralgia	Nervous system disorders	MedDRA	Systematic Assessment	EG00038 affected381 at risk EG00144 affected377 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA	Systematic Assessment	EG000117 affected381 at risk EG001133 affected377 at risk
Paraesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG00024 affected381 at risk EG00127 affected377 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA	Systematic Assessment	EG00042 affected381 at risk EG00146 affected377 at risk
Polyneuropathy	Nervous system disorders	MedDRA	Systematic Assessment	EG00028 affected381 at risk EG00128 affected377 at risk
Insomnia	Psychiatric disorders	MedDRA	Systematic Assessment	EG00073 affected381 at risk EG00161 affected377 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00081 affected381 at risk EG00170 affected377 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00053 affected381 at risk EG00140 affected377 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00033 affected381 at risk EG00123 affected377 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG00027 affected381 at risk EG00123 affected377 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG00049 affected381 at risk EG00134 affected377 at risk
Orthostatic hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG00022 affected381 at risk EG00111 affected377 at risk

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PAN+BTZ	Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.			228	381	379	381
EG001	PBO+BTZ	Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day..			157	377	366	377

ID	Term
D009101	Multiple Myeloma
D054219	Neoplasms, Plasma Cell
D012008	Recurrence

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006474	Hemorrhagic Disorders
D008232	Lymphoproliferative Disorders
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D006877	Hydroxamic Acids
D006898	Hydroxylamines
D000588	Amines
D009930	Organic Chemicals
D006880	Hydroxy Acids
D002264	Carboxylic Acids
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D001897	Boronic Acids
D000148	Acids, Noncarboxylic
D000143	Acids
D007287	Inorganic Chemicals
D001896	Boron Compounds
D011719	Pyrazines
D006573	Heterocyclic Compounds, 1-Ring
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated

ID	Title	Description
BG000	Panobinostat + Bortezomib	Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
BG001	Placebo + Bortezomib	Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
BG002	Total	Total of all reporting groups

ID	Term
D000077767	Panobinostat
D000069286	Bortezomib
D003907	Dexamethasone