A Study Evaluating the Addition of MabThera (Rituximab) t... | NCT00770562

NCT00770562

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dexamethasone	Active Comparator	Participants received 40 milligrams (mg) dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of less than or equal to (≤)20 x 10^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m^2), intravenously (IV), with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.	Drug: Dexamethasone
Dexamethasone plus Rituximab	Experimental	Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets less than (<) 20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with immunoglobulin (IgG) IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.	Drug: rituximab Drug: Dexamethasone

Name	Type	Description	Arm Group Labels	Other Names
rituximab	Drug		Dexamethasone plus Rituximab	MabThera/Rituxan
Dexamethasone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With a Sustained Response	Sustained response defined as a platelet count of greater than or equal to (≥) 50x10^9/L at 6 months (Week 24) after the initial treatment. Participants failing therapy before Month 6 (Week 24) and treated in other ways were considered failures.	Week 24

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With an Initial Response	Initial response was defined as an increase in platelet count of ≥50x10^9/L by Day 30 (Week 4) after the start of treatment in either treatment arm.	Week 4
Percentage of Participants With an Initial Complete Response

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Chair

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20130241	Derived	Zaja F, Baccarani M, Mazza P, Bocchia M, Gugliotta L, Zaccaria A, Vianelli N, Defina M, Tieghi A, Amadori S, Campagna S, Ferrara F, Angelucci E, Usala E, Cantoni S, Visani G, Fornaro A, Rizzi R, De Stefano V, Casulli F, Battista ML, Isola M, Soldano F, Gamba E, Fanin R. Dexamethasone plus rituximab yields higher sustained response rates than dexamethasone monotherapy in adults with primary immune thrombocytopenia. Blood. 2010 Apr 8;115(14):2755-62. doi: 10.1182/blood-2009-07-229815. Epub 2010 Feb 3.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Arm A: Dexamethasone	Participants received 40 milligrams (mg) dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of less than or equal to (≤)20 x 10^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m^2), intravenously (IV), with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Arm A: Dexamethasone	Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
BG001	Arm B: Dexamethasone + Rituximab	Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m^2), IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets <20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00052 BG00149 BG002101

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00036 OG00163

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Fisher Exact		0.004													No	Superiority or Other

Secondary

Percentage of Participants With an Initial Response

Initial response was defined as an increase in platelet count of ≥50x10^9/L by Day 30 (Week 4) after the start of treatment in either treatment arm.

ITT population; excluding participants who received additional steroid therapy or IV Ig course during the first month of therapy.

Posted

Number

percentage of participants

Week 4

ID	Title	Description
OG000	Arm A: Dexamethasone	Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
OG001	Arm B: Dexamethasone + Rituximab	Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets <20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.

Secondary

Percentage of Participants With an Initial Complete Response

Initial complete response was defined as an increase in platelet count of ≥100x10^9/L by Day 30 (Week 4) after the initiation of treatment in either treatment arm.

ITT population; excluding participants who received additional steroid therapy or IV Ig course during the first month of therapy.

Posted

Number

percentage of participants

Week 4

ID	Title	Description
OG000	Arm A: Dexamethasone	Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
OG001	Arm B: Dexamethasone + Rituximab	Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets <20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm A: Dexamethasone	Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4).	1	52	25	52
EG001	Arm B: Dexamethasone + Rituximab	Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.	3	49	37	49
EG002	Salvage Therapy	Nonresponsive (failed to achieve a sustained response) participants from Arm A (dexamethasone monotherapy) who had a platelet count of ≤20 x 10^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants from Arm B (dexamethasone + rituximab) with platelets <20 x10^9/L or with active bleeding were treated with salvage therapy of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.	3	27	18	27

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hemorrhage syndrome	Blood and lymphatic system disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Platelet count decreased	Blood and lymphatic system disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Interstitial pneumonia	Infections and infestations	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Convulsion	Nervous system disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Seizure	Nervous system disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
TIA	Nervous system disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Hemorrhagic syndrome and low platelet	Blood and lymphatic system disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v.3.0	Non-systematic Assessment	EG0002 affected52 at risk EG0012 affected49 at risk EG0021 affected27 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0022 affected27 at risk
Arrhythmia	Cardiac disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Bradycardia	Cardiac disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Conjunctivitis	Eye disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0017 affected49 at risk EG0022 affected27 at risk
Constipation	Gastrointestinal disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0011 affected49 at risk EG0022 affected27 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0015 affected49 at risk EG0020 affected27 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Dysphagia	Gastrointestinal disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Gastritis	Gastrointestinal disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0013 affected49 at risk EG0021 affected27 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Vomiting	Gastrointestinal disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Adverse drug reaction	General disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Asthenia	General disorders	MedDRA v.3.0	Non-systematic Assessment	EG0002 affected52 at risk EG0015 affected49 at risk EG0020 affected27 at risk
Chest pain	General disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Chills	General disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0012 affected49 at risk EG0020 affected27 at risk
Fatigue	General disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Gravitational oedema	General disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Hyperpyrexia	General disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Malaise	General disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Mucosal hyperaemia	General disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Mucosal inflammation	General disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Oedema peripheral	General disorders	MedDRA v.3.0	Non-systematic Assessment	EG0002 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Pyrexia	General disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG00110 affected49 at risk EG0025 affected27 at risk
Biliary colic	Hepatobiliary disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Hypersensitivity	Immune system disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0012 affected49 at risk EG0020 affected27 at risk
Acute sinusitis	Infections and infestations	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Bronchitis acute	Infections and infestations	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Cystitis	Infections and infestations	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Folliculitis	Infections and infestations	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Gastroenteritis	Infections and infestations	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0012 affected49 at risk EG0020 affected27 at risk
Helicobacter infection	Infections and infestations	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0012 affected49 at risk EG0020 affected27 at risk
Herpes simplex	Infections and infestations	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Herpes zoster	Infections and infestations	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Influenza	Infections and infestations	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0012 affected49 at risk EG0020 affected27 at risk
Lung infection	Infections and infestations	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Nasopharyngitis	Infections and infestations	MedDRA v.3.0	Non-systematic Assessment	EG0002 affected52 at risk EG0014 affected49 at risk EG0020 affected27 at risk
Pharyngitis	Infections and infestations	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0012 affected49 at risk EG0020 affected27 at risk
Tinea versicolour	Infections and infestations	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Tooth abscess	Infections and infestations	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0012 affected49 at risk EG0022 affected27 at risk
Tracheitis	Infections and infestations	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Urinary tract infection	Infections and infestations	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Injury	Injury, poisoning and procedural complications	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Traumatic haemorrhage	Injury, poisoning and procedural complications	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Blood amylase increased	Investigations	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Blood pressure abnormal	Investigations	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Blood pressure increased	Investigations	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Lipase increased	Investigations	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Oxygen saturation decreased	Investigations	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Platelet count decreased	Investigations	MedDRA v.3.0	Non-systematic Assessment	EG0002 affected52 at risk EG0010 affected49 at risk EG0022 affected27 at risk
Transaminases increased	Investigations	MedDRA v.3.0	Non-systematic Assessment	EG0003 affected52 at risk EG0012 affected49 at risk EG0020 affected27 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0012 affected49 at risk EG0020 affected27 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0021 affected27 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0011 affected49 at risk EG0022 affected27 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0012 affected49 at risk EG0020 affected27 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Cognitive disorder	Nervous system disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Dizziness	Nervous system disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0011 affected49 at risk EG0021 affected27 at risk
Headache	Nervous system disorders	MedDRA v.3.0	Non-systematic Assessment	EG0003 affected52 at risk EG0016 affected49 at risk EG0022 affected27 at risk
Neuralgia	Nervous system disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Anxiety	Psychiatric disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Depression	Psychiatric disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0012 affected49 at risk EG0020 affected27 at risk
Insomnia	Psychiatric disorders	MedDRA v.3.0	Non-systematic Assessment	EG0002 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Dysuria	Renal and urinary disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Renal colic	Renal and urinary disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Renal failure acute	Renal and urinary disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Strangury	Renal and urinary disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0012 affected49 at risk EG0020 affected27 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v.3.0	Non-systematic Assessment	EG0005 affected52 at risk EG0016 affected49 at risk EG0020 affected27 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0013 affected49 at risk EG0020 affected27 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Tonsillar disorder	Respiratory, thoracic and mediastinal disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0012 affected49 at risk EG0021 affected27 at risk
Periorbital oedema	Skin and subcutaneous tissue disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA v.3.0	Non-systematic Assessment	EG0004 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA v.3.0	Non-systematic Assessment	EG0002 affected52 at risk EG0010 affected49 at risk EG0020 affected27 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Arteriosclerosis	Vascular disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected49 at risk EG0021 affected27 at risk
Hypertension	Vascular disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk
Hypotension	Vascular disorders	MedDRA v.3.0	Non-systematic Assessment	EG0001 affected52 at risk EG0011 affected49 at risk EG0021 affected27 at risk
Phlebitis superficial	Vascular disorders	MedDRA v.3.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected49 at risk EG0020 affected27 at risk

ID	Term
D016553	Purpura, Thrombocytopenic, Idiopathic

Ancestor Terms

ID	Term
D011696	Purpura, Thrombocytopenic
D011693	Purpura
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D057049	Thrombotic Microangiopathies
D013921	Thrombocytopenia
D001791	Blood Platelet Disorders
D000095542	Cytopenia
D006474	Hemorrhagic Disorders
D001327	Autoimmune Diseases
D007154	Immune System Diseases
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012877	Skin Manifestations
D012816	Signs and Symptoms

ID	Term
D000069283	Rituximab
D003907	Dexamethasone

Ancestor Terms

ID	Term
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated

Facility	Status	City	State	ZIP	Country	Contacts
		Bari		70124	Italy