Octreotide Compared to Placebo in Patients With Inoperabl... | NCT00332696

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Octreotide	Experimental	Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.	Drug: Octreotide LAR Drug: Octreotide (Immediate release) Drug: methylprednisolone
Placebo	Placebo Comparator	Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.	Drug: methylprednisolone Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Octreotide LAR	Drug	Octreotide long-acting release (LAR) 30 mg intramuscular injection.	Octreotide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment Success From Day 10 to Day 13	Treatment Success was defined as: less than 2 episodes of vomiting on average per day for the 4 days prior to Day 14 [from Day 10 to Day 13] and no use of an Nasogastric Tube (NGT) since at least Day 10 and no use of an anticholinergic agent until Day 14. Treatment Failure is defined as: 2 or more episodes of vomiting per day on average for the 4 days prior to Day 14 or use of an NGT after Day 9 or use of an anticholinergic agent before Day 14 or withdrawal from the trial between Day 1 and Day 14 (included), whatever the cause.	Day 10 to Day 13

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment Success From Day 5 to Day 7	Day 7 treatment success was defined as improvement of symptoms in the previous 2 days (average number of vomiting episodes less than 2 from Day 5, no Nasogastric Tube (NGT) since Day 5 and no anticholinergic agent or withdrawal from trial).	Day 5 to Day 7

Eligibility Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Octreotide	Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	Octreotide	Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
BG001	Placebo	Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00032 BG00132 BG00264

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

Number of Participants With Treatment Success From Day 10 to Day 13

Treatment Success was defined as: less than 2 episodes of vomiting on average per day for the 4 days prior to Day 14 [from Day 10 to Day 13] and no use of an Nasogastric Tube (NGT) since at least Day 10 and no use of an anticholinergic agent until Day 14.

Treatment Failure is defined as: 2 or more episodes of vomiting per day on average for the 4 days prior to Day 14 or use of an NGT after Day 9 or use of an anticholinergic agent before Day 14 or withdrawal from the trial between Day 1 and Day 14 (included), whatever the cause.

Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.

Posted

Number

Participants

Day 10 to Day 13

ID	Title	Description
OG000	Octreotide	Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
OG001	Placebo	Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.

Units	Counts
Participants	OG00032 OG00132

Title

Denominators

Categories

TREATMENT SUCCESS

Title	Measurements
	OG00012 OG0019

Vomiting episodes <2 (per day)

Title	Measurements
	OG000

Secondary

Number of Participants With Treatment Success From Day 5 to Day 7

Day 7 treatment success was defined as improvement of symptoms in the previous 2 days (average number of vomiting episodes less than 2 from Day 5, no Nasogastric Tube (NGT) since Day 5 and no anticholinergic agent or withdrawal from trial).

Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.

Posted

Number

Participants

Day 5 to Day 7

ID	Title	Description
OG000	Octreotide	Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
OG001	Placebo	Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.

Secondary

Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14

The mean number of vomiting episodes per a 24 hour period is presented for Day 1, Day 7 and Day 14.

Intent-to-treat population consisted of all randomized participants who received study drug. "n" in each of the categories is the number of participants with data at the given time point.

Posted

Mean

Standard Deviation

Vomiting episodes

Day 1, Day 7 and Day 14

ID	Title	Description
OG000	Octreotide	Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
OG001	Placebo	Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.

Secondary

Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1

Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 1.

Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.

Posted

Number

Participants

Day 1

ID	Title	Description
OG000	Octreotide	Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
OG001	Placebo	Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.

Secondary

Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7

Participants from the Intent-to-treat population consisting of all randomized participants who received study drug and for whom data was available at Day 7.

Posted

Number

Participants

Day 7

ID	Title	Description
OG000	Octreotide	Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
OG001	Placebo	Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.

Secondary

Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14

Participants from the Intent-to-treat population consisting of all randomized participants who received study drug and for whom data was available at Day 14.

Posted

Number

Participants

Day 14

ID	Title	Description
OG000	Octreotide	Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
OG001	Placebo	Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.

Secondary

Number of Participants With Relief From Obstruction at Day 7 and Day 14

Relief from obstruction is defined by combining restart of stools for at least the previous 3 days, less than 2 episodes of vomiting on average for the previous 4 days and the restarting of flatus (gas generated in the stomach or bowels) for at least the previous 12 hours.

Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.

Posted

Number

Participants

Day 7 and Day 14

ID	Title	Description
OG000	Octreotide	Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
OG001	Placebo	Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.

Secondary

Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1

Recurrence of bowel obstruction was confirmed by abdominal X-ray.

Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 1.

Posted

Number

Participants

1 Month

ID	Title	Description
OG000	Octreotide	Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
OG001	Placebo	Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.

Secondary

Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2

Recurrence of bowel obstruction was confirmed by abdominal X-ray.

Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 2.

Posted

Number

Participants

Month 2

ID	Title	Description
OG000	Octreotide	Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
OG001	Placebo	Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.

Secondary

Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3

Recurrence of bowel obstruction was confirmed by abdominal X-ray.

Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 3.

Posted

Number

Participants

Month 3

ID	Title	Description
OG000	Octreotide	Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
OG001	Placebo	Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.

Secondary

Participant's Quality of Life Using the Edmonton Scale

The Edmonton Scale consisted of 9 items: pain, activity, nausea, depression, anxiety, fatigue, appetite, sensation of well-being and dyspnea (difficult or labored breathing). Participants rated these items on a scale of 0 to 10, with 10 being the worse.

Intent-to-treat population consisted of all participants who received at least one dose of study drug. "n" in each of the categories is the number of participants who had Quality of Life data at that time point.

Posted

Mean

Standard Deviation

Scores on a scale

Day 1, Day 7, Day 14, Month 1, Month 2 and Month 3

ID	Title	Description
OG000	Octreotide	Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
OG001	Placebo	Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.

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	Octreotide	Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.			6	32	24	32
EG001	Placebo	Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.			6	32	19	32

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac arrest	Cardiac disorders	MedDRA 10.X	Systematic Assessment	EG0001 affected32 at risk EG0010 affected32 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10.X	Systematic Assessment	EG0000 affected32 at risk EG0011 affected32 at risk
Ascites	Gastrointestinal disorders	MedDRA 10.X	Systematic Assessment	EG0001 affected32 at risk EG0010 affected32 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 10.X	Systematic Assessment	EG0000 affected32 at risk EG0011 affected32 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10.X	Systematic Assessment	EG0000 affected32 at risk EG0011 affected32 at risk
Disease progression	General disorders	MedDRA 10.X	Systematic Assessment	EG0000 affected32 at risk EG0011 affected32 at risk
General physical health deterioration	General disorders	MedDRA 10.X	Systematic Assessment	EG0001 affected32 at risk EG0013 affected32 at risk
Hyperthermia	General disorders	MedDRA 10.X	Systematic Assessment	EG0001 affected32 at risk EG0011 affected32 at risk
Oedema	General disorders	MedDRA 10.X	Systematic Assessment	EG0001 affected32 at risk EG0010 affected32 at risk
Oedema peripheral	General disorders	MedDRA 10.X	Systematic Assessment	EG0000 affected32 at risk EG0011 affected32 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 10.X	Systematic Assessment	EG0001 affected32 at risk EG0010 affected32 at risk
Cytolytic hepatitis	Hepatobiliary disorders	MedDRA 10.X	Systematic Assessment	EG0001 affected32 at risk EG0010 affected32 at risk
Sepsis	Infections and infestations	MedDRA 10.X	Systematic Assessment	EG0001 affected32 at risk EG0012 affected32 at risk
Septic shock	Infections and infestations	MedDRA 10.X	Systematic Assessment	EG0001 affected32 at risk EG0011 affected32 at risk
Staphylococcal infection	Infections and infestations	MedDRA 10.X	Systematic Assessment	EG0001 affected32 at risk EG0010 affected32 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 10.X	Systematic Assessment	EG0000 affected32 at risk EG0011 affected32 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 10.X	Systematic Assessment	EG0001 affected32 at risk EG0010 affected32 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 10.X	Systematic Assessment	EG0001 affected32 at risk EG0010 affected32 at risk
Coma	Nervous system disorders	MedDRA 10.X	Systematic Assessment	EG0001 affected32 at risk EG0010 affected32 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 10.X	Systematic Assessment	EG0001 affected32 at risk EG0010 affected32 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 10.X	Systematic Assessment	EG0001 affected32 at risk EG0010 affected32 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 10.X	Systematic Assessment	EG0000 affected32 at risk EG0012 affected32 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.X	Systematic Assessment	EG0000 affected32 at risk EG0012 affected32 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 10.X	Systematic Assessment	EG0000 affected32 at risk EG0011 affected32 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 10.X	Systematic Assessment	EG0000 affected32 at risk EG0011 affected32 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.X	Systematic Assessment	EG0000 affected32 at risk EG0011 affected32 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 10.X	Systematic Assessment	EG0000 affected32 at risk EG0011 affected32 at risk
Ileostomy	Surgical and medical procedures	MedDRA 10.X	Systematic Assessment	EG0000 affected32 at risk EG0011 affected32 at risk
Laparotomy	Surgical and medical procedures	MedDRA 10.X	Systematic Assessment	EG0000 affected32 at risk EG0011 affected32 at risk
Hypotension	Vascular disorders	MedDRA 10.X	Systematic Assessment	EG0000 affected32 at risk EG0011 affected32 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 10.X	Systematic Assessment	EG0002 affected32 at risk EG0011 affected32 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 10.X	Systematic Assessment	EG0001 affected32 at risk EG0012 affected32 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 10.X	Systematic Assessment	EG0000 affected32 at risk EG0012 affected32 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10.X	Systematic Assessment	EG0007 affected32 at risk EG0014 affected32 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.X	Systematic Assessment	EG0005 affected32 at risk EG0013 affected32 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 10.X	Systematic Assessment	EG0003 affected32 at risk EG0010 affected32 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 10.X	Systematic Assessment	EG0001 affected32 at risk EG0012 affected32 at risk
Melaena	Gastrointestinal disorders	MedDRA 10.X	Systematic Assessment	EG0000 affected32 at risk EG0012 affected32 at risk
Nausea	Gastrointestinal disorders	MedDRA 10.X	Systematic Assessment	EG0007 affected32 at risk EG0012 affected32 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10.X	Systematic Assessment	EG0006 affected32 at risk EG0015 affected32 at risk
Asthenia	General disorders	MedDRA 10.X	Systematic Assessment	EG0007 affected32 at risk EG0013 affected32 at risk
Chills	General disorders	MedDRA 10.X	Systematic Assessment	EG0002 affected32 at risk EG0010 affected32 at risk
Condition aggravated	General disorders	MedDRA 10.X	Systematic Assessment	EG0003 affected32 at risk EG0011 affected32 at risk
Disease progression	General disorders	MedDRA 10.X	Systematic Assessment	EG0007 affected32 at risk EG0012 affected32 at risk
Fatigue	General disorders	MedDRA 10.X	Systematic Assessment	EG0003 affected32 at risk EG0011 affected32 at risk
General physical health deterioration	General disorders	MedDRA 10.X	Systematic Assessment	EG0003 affected32 at risk EG0013 affected32 at risk
Hypothermia	General disorders	MedDRA 10.X	Systematic Assessment	EG0002 affected32 at risk EG0010 affected32 at risk
Oedema	General disorders	MedDRA 10.X	Systematic Assessment	EG0002 affected32 at risk EG0010 affected32 at risk
Oedema peripheral	General disorders	MedDRA 10.X	Systematic Assessment	EG0002 affected32 at risk EG0013 affected32 at risk
Pain	General disorders	MedDRA 10.X	Systematic Assessment	EG0001 affected32 at risk EG0012 affected32 at risk
Pyrexia	General disorders	MedDRA 10.X	Systematic Assessment	EG0003 affected32 at risk EG0011 affected32 at risk
Jaundice	Hepatobiliary disorders	MedDRA 10.X	Systematic Assessment	EG0002 affected32 at risk EG0011 affected32 at risk
Oral fungal infection	Infections and infestations	MedDRA 10.X	Systematic Assessment	EG0002 affected32 at risk EG0010 affected32 at risk
Sepsis	Infections and infestations	MedDRA 10.X	Systematic Assessment	EG0001 affected32 at risk EG0012 affected32 at risk
Septic shock	Infections and infestations	MedDRA 10.X	Systematic Assessment	EG0002 affected32 at risk EG0011 affected32 at risk
Urinary tract infection	Infections and infestations	MedDRA 10.X	Systematic Assessment	EG0003 affected32 at risk EG0011 affected32 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 10.X	Systematic Assessment	EG0001 affected32 at risk EG0012 affected32 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 10.X	Systematic Assessment	EG0002 affected32 at risk EG0012 affected32 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 10.X	Systematic Assessment	EG0004 affected32 at risk EG0010 affected32 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 10.X	Systematic Assessment	EG0002 affected32 at risk EG0010 affected32 at risk
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.X	Systematic Assessment	EG0003 affected32 at risk EG0011 affected32 at risk
Headache	Nervous system disorders	MedDRA 10.X	Systematic Assessment	EG0002 affected32 at risk EG0011 affected32 at risk
Anxiety	Psychiatric disorders	MedDRA 10.X	Systematic Assessment	EG0003 affected32 at risk EG0014 affected32 at risk
Confusional state	Psychiatric disorders	MedDRA 10.X	Systematic Assessment	EG0004 affected32 at risk EG0012 affected32 at risk
Disorientation	Psychiatric disorders	MedDRA 10.X	Systematic Assessment	EG0002 affected32 at risk EG0010 affected32 at risk
Insomnia	Psychiatric disorders	MedDRA 10.X	Systematic Assessment	EG0002 affected32 at risk EG0011 affected32 at risk
Dysuria	Renal and urinary disorders	MedDRA 10.X	Systematic Assessment	EG0002 affected32 at risk EG0010 affected32 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 10.X	Systematic Assessment	EG0003 affected32 at risk EG0010 affected32 at risk
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 10.X	Systematic Assessment	EG0000 affected32 at risk EG0013 affected32 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.X	Systematic Assessment	EG0005 affected32 at risk EG0013 affected32 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.X	Systematic Assessment	EG0000 affected32 at risk EG0012 affected32 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 10.X	Systematic Assessment	EG0002 affected32 at risk EG0010 affected32 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 10.X	Systematic Assessment	EG0002 affected32 at risk EG0010 affected32 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 10.X	Systematic Assessment	EG0003 affected32 at risk EG0010 affected32 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 10.X	Systematic Assessment	EG0002 affected32 at risk EG0010 affected32 at risk

ID	Term
D010534	Peritoneal Neoplasms
D007415	Intestinal Obstruction
D002277	Carcinoma

ID	Term
D000008	Abdominal Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004067	Digestive System Neoplasms
D004066	Digestive System Diseases
D010532	Peritoneal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

ID	Term
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011239	Prednisolone
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds