Study In Patients With Depression Not Responding to Selec... | NCT00296517

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Subjects with Major Depressive Disorder who were randomised to placebo to match Bupropion SR during the treatment period.	Drug: Placebo
Bupropion SR	Experimental	Subjects with Major Depressive Disorder who were randomized to take 100mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100mg dose of Bupropion morning and evening. Weeks 3 thru 12 received 150mg dose morning and evening. Week 1=dose level 1, 100 mg. Week 2=dose level 2, 200 mg. Weeks 3 - 12=dose level 3, 300 mg.	Drug: 323U66 (Bupropion Hydrochloride Sustained Release)

Name	Type	Description	Arm Group Labels	Other Names
323U66 (Bupropion Hydrochloride Sustained Release)	Drug	Subjects with Major Depressive Disorder who were randomized to take 100mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100mg dose of Bupropion morning and evening. Weeks 3 thru 12 received 150mg dose morning and evening. Week 1=dose level 1, 100 mg. Week 2=dose level 2, 200 mg. Weeks 3 - 12=dose level 3, 300 mg.

Measure	Description	Time Frame
Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score	The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).	Baseline and Week 12

Measure	Description	Time Frame
Hamilton Depression Scale (HAM-D 17 Items) Total Score	The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).	Week 8 and Week 12

Eligibility Module

Eligibility Criteria

Inclusion criteria:

[At the start of the pretreatment phase]
Target disease: Patients diagnosed as having the following primary disease on the basis of DSM-IV-TR criteria.
Major Depressive Disorder, Single Episode (296.2x) (excluding with psychotic features)
Major Depressive Disorder, Recurrent (296.3x) (excluding with psychotic features)
HAM-D (17 items) total score is >=16.
Patients who have been treated with marketed paroxetine (Paxil®) at 20mg/day to 40mg/day for 4 weeks and more at the start of the pretreatment phase.
Age: >=18 years old (at the time of informed consent) , <65 years old (at the start of treatment phase )
Gender: Male or female.
Inpatients or outpatients: Either
Informed consent: The subject himself/herself must give written informed consent. However, if the subject is under 20 at the time of giving consent, both the subject himself/herself and his/her legally acceptable representative must give written informed consent.

[At the end of the pretreatment phase]

HAM-D (17 items) total score is ≥14.
Percentage of change from the start of the pretreatment phase in the HAM-D (17 items) total score is <50%

[At the start of the treatment phase]

HAM-D (17 items) total score is ≥14.
Percentage of change from the start of the pretreatment phase in the HAM-D (17 items) total score is <50%

Exclusion Criteria:

[At the start of the pre-treatment phase]

Patients with a complication of glaucoma
Patients concomitantly using a drug increasing the risk of bleeding and patients with bleeding tendency or predisposition to bleeding
Patients with predisposition to seizure (who currently have or have a past history of seizure, febrile convulsive seizure in infancy, cerebral tumour, cerebrovascular disorder or head injury, who have a family history of idiopathic seizure, patients with diabetes who have been treated with oral hypoglycaemics or insulin, or who use drugs lowering the threshold of seizure).
Patients who currently have or have a past history of the following disorders:
Anorexia nervosa (DSM-IV-TR 307.1)
Bulimia nervosa (DSM-IV-TR 307.51)
Patients with a history of manic episode
Patients with a past or current DSM- IV-TR diagnosis of schizophrenia or other psychotic disorder
Patients with a current DSM-IV-TR Axis II diagnosis (e.g., antisocial or borderline personality disorder)
Patients starting psychotherapy (except for supportive psychotherapy not aimed at therapeutic efficacy and unlikely to affect efficacy evaluation) and formal cognitive behaviour therapy within 5 weeks prior to the start of the pre-treatment phase
Patients with a diagnosis of substance abuse (alcohol or drug) by the DSM-IV-TR criteria or with a diagnosis of substance dependence within 1 year prior to the start of the pre-treatment phase
Patients who have received electroconvulsive therapy within 17 weeks prior to the start of the pre-treatment phase
Patients who have taken MAO inhibitors (selegiline hydrochloride) within 2 weeks prior to the start of the pre-treatment phase
Patients who have taken another investigational drug within 12 weeks prior to the start of the pre-treatment phase
Female patients who are pregnant, possibly pregnant or are nursing, and those who want to become pregnant before 30 days after the last dose of the investigational product
Patients who have attempted suicide within 17 weeks prior to the start of the pre-treatment phase, or patients for whom the score of suicide-related item No. 3 of HAM-D is >=3, or patients in whom the risk of suicide is judged to be high by the investigator (sub-investigator)
Patients in whom the risk of homicide is judged to be high by the investigator (sub-investigator)
Patients with a history of hypersensitivity to 323U66 and/or paroxetine
Patients with serious cerebral disease
Patients who have ECG or clinical evidence of any cardiac condition that the investigator (sub-investigator) feels may predispose the subject to ischemia or arrhythmia
Patients with serious physical symptoms (i.e. cardiac/hepatic/renal disorder, hematopoietic disorder) The index of seriousness is Grade 3 of "Criteria for classification of seriousness of adverse drug reactions to pharmaceutical products, etc." (PAB/PSD No.80 in 1992).
Patients with a history or complication of cancer or malignant tumour.
Patients whose major depressive disorder is due to direct physiological effects of a general medical condition (for example, hypothyroidism, Parkinson's disease, chronic pain)
Patients with systolic blood pressure of >=160 mmHg or diastolic blood pressure of >=100 mmHg
Patients who are inappropriate for participating in the study in the judgement of the investigator (sub-investigator)

[At the start of the treatment phase]

Patients whose compliance of paroxetine during the pretreatment phase is less than 70%.
Patients who have ECG or clinical evidence of any cardiac condition that the investigator (sub-investigator) feels may predispose the subject to ischemia or arrhythmia
Patients with systolic blood pressure of >=160 mmHg or diastolic blood pressure of >=100 mmHg

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Aichi		462-0831	Japan
GSK Investigational Site

ID	Title	Description
FG000	Placebo	Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
FG001	Bupropion SR	Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.

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

Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score

The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).

Full Analysis Set was all subjects who entered the treatment phase with the exception of those who did not take any investigational products during the treatment phase and those who did not meet the major eligibility criteria of Major Depressive Disorder or those with no valid post baseline assessment. Week 12/LOCF placebo = 155, Bupropion SR = 160

Posted

Mean

Standard Deviation

Score in scale

Baseline and Week 12

ID	Title	Description
OG000	Placebo	Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
OG001	Bupropion SR	Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.

Units	Counts
Participants	OG000157 OG001165

Title

Denominators

Categories

Baseline

Title	Measurements
	OG00019.8± 4.34 OG00119.4± 4.39

Week 12 or Last Observation Carried Forward

Title	Measurements
	OG000

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	Null Hypothesis: The population mean change from baseline on HAM-D total score at Week 12 of the placebo group is equal to the population mean change from baseline on HAMD total score at Week 12 of the Bupropion hydrochloride sustained release group.	ANOVA		0.805		Mean Difference (Net)	0.2				95	-1.6	2.0					Superiority or Other (legacy)

Secondary

Hamilton Depression Scale (HAM-D 17 Items) Total Score

Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Observed Cases: placebo = 111, Bupropion = 98

Posted

Mean

Standard Deviation

Score in scale

Week 8 and Week 12

ID	Title	Description
OG000	Placebo	Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
OG001	Bupropion SR	Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.

Units	Counts

Secondary

Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score at Week 8 and Total Score at Week 12

Posted

Mean

Standard Deviation

Score in a scale

Baseline to Week 8 and Week 12

ID	Title	Description
OG000	Placebo	Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
OG001	Bupropion SR	Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.

Secondary

Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12.

Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Last Observation Carried Forward: placebo = 155, Bupropion = 160 Week 12 Observed Cases: placebo = 111, Bupropion = 98

Posted

Mean

Standard Deviation

Percent Change in score

Baseline to Week 8 and Week 12

ID	Title	Description
OG000	Placebo	Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
OG001	Bupropion SR	Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.

Secondary

Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12

Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Last Observation Carried Forward: placebo = 155, Bupropion = 160, Week 12 Observed Cases: placebo = 111, Bupropion = 98

Posted

Mean

95% Confidence Interval

Percentage of Responders

Baseline to Week 8 and Week 12

ID	Title	Description
OG000	Placebo	Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
OG001	Bupropion SR	Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.

Secondary

Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12

Posted

Mean

95% Confidence Interval

Percentage of Remitters

Baseline to Week 8 and Week 12

ID	Title	Description
OG000	Placebo	Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
OG001	Bupropion SR	Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.

Secondary

Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12

The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2, with total HAM-D scores ranging from 0 (not ill) to 54 (severely ill).

Full Analysis Set. Week 8 Last Observation Carried Forward (LOCF): placebo=152, Bupropion=160; Week 12 LOCF: placebo=155, Bupropion=160. Gastrointestinal, GI.

Posted

Mean

Standard Deviation

points on a scale

Baseline to Week 8 and Week 12

ID	Title	Description
OG000	Placebo	Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
OG001	Bupropion SR	Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.

Units	Counts

Secondary

Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12

Full Analysis Set. Last Observation Carried Forward, LOCF; Gastrointestinal, GI; Somatic, Som.; General, Gen.; Week, W.

Posted

Mean

Standard Deviation

percent change in score

Baseline to Week 8 and Week 12

ID	Title	Description
OG000	Placebo	Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
OG001	Bupropion SR	Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.

Units	Counts

Secondary

Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12

The 7-point Clinical Global Impressions-Severity of Illness Scale (CGI-S) measures the severity of psychiatric symptoms. The following scores can be given: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill patients.

Full Analysis Set

Posted

Mean

Standard Deviation

Points on scale

Baseline to Weeks 1, 2, 3, 4, 8, and 12

ID	Title	Description
OG000	Placebo	Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
OG001	Bupropion SR	Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.

Units	Counts

Secondary

Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12

The CGI-I assesses the investigator's impression of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (very much improved) to 7 (very much worse). Responders are subjects that have a score of 1 (very much improved) or 2 (much improved) on the CGI-I.

Full Analysis set. Week 8 Last Observation Carried Forward: placebo = 153, Bupropion = 159; Week 8 Observed Cases: placebo = 113, Bupropion = 106; Week 12 Last Observation Carried Forward: placebo = 156, Bupropion = 158; Week 12 Observed Cases: placebo = 111, Bupropion = 98

Posted

Mean

95% Confidence Interval

Percentage of Responders

Baseline to Week 8 and Week 12

ID	Title	Description
OG000	Placebo	Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
OG001	Bupropion SR	Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.

Secondary

Study Continuation Rate as Assessed by the Number of Participants at Risk at Week 12

Kaplan-Meier estimates were calculated using event or censoring and time to event or censoring. Participants at risk refers to participants with either a censoring or event time beyond the time point of interest (Week 12).

Full analysis set. Participants at risk refers to participants with either a censoring or event time beyond the time point of interest (Week 12).

Posted

Number

participants

Week 12

ID	Title	Description
OG000	Placebo	Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
OG001	Bupropion SR	Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.

Units	Counts
Participants

Secondary

Safety: Adverse Events by Organ System Class, Intensity, and Frequency

Assessment of intensity was based on investigators/subinvestigator's clinical judgement per protocol instructions: Mild event, easily tolerated, with minimal discomfort and not interfering with Activities of Daily Living (ADLs); moderate event, with discomfort that interferes with ADLs; severe event, prevents ADLs.

Safety population: comprised of participants who took at least one dose of the treatment period investigational product. The number of participants analyzed for this outcome measure represents the total number of events at each intensity.

Posted

Number

Number of events

Baseline to Week 12

ID	Title	Description
OG000	Placebo	Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
OG001	Bupropion SR	Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.

Title

Denominators

Categories

Nervous System Disorders (NSD) - Any Event, mild

Title	Measurements
	OG00032 OG00131

NSD - Any Event, moderate

Title	Measurements
	OG0008 OG00116

NSD - Any Event, severe

Title	Measurements
	OG0001 OG0013

NSD - Dizziness, mild

Title	Measurements
	OG00011 OG0018

NSD - Dizziness, moderate

Title	Measurements
	OG0004 OG0018

NSD - Dizziness, severe

Title	Measurements
	OG0001 OG0010

NSD - Headache, mild

Title	Measurements
	OG0006 OG0018

NSD - Headache, moderate

Title	Measurements
	OG0003 OG0016

NSD - Headache, severe

Title	Measurements
	OG0000 OG0011

NSD - Somnolence, mild

Title	Measurements
	OG00010 OG0018

NSD - Somnolence, moderate

Title	Measurements
	OG0000 OG0010

NSD - Somnolence, severe

Title	Measurements
	OG0000 OG0010

NSD - Hypoesthesia, mild

Title	Measurements
	OG0005 OG0011

NSD - Hypoesthesia, moderate

Title	Measurements
	OG0001 OG0010

NSD - Hypoesthesia, severe

Title	Measurements
	OG0000 OG0010

NSD - Dysgeusia, mild

Title	Measurements
	OG0000 OG0014

NSD - Dysgeusia, moderate

Title	Measurements
	OG0000 OG0011

NSD - Dysgeusia, severe

Title	Measurements
	OG0000 OG0010

NSD - Depressed Level of Consciousness, mild

Title	Measurements
	OG0000 OG0011

NSD - Depressed Level of Consciousness, moderate

Title	Measurements
	OG0000 OG0012

NSD - Depressed Level of Consciousness, severe

Title	Measurements
	OG0000 OG0011

NSD - Tremor, mild

Title	Measurements
	OG0000 OG0014

NSD - Tremor, moderate

Title	Measurements
	OG0000 OG0010

NSD - Tremor, severe

Title	Measurements
	OG0000 OG0010

NSD - Convulsion, mild

Title	Measurements
	OG0000 OG0010

NSD - Convulsion, moderate

Title	Measurements
	OG0000 OG0011

NSD - Convulsion, severe

Title	Measurements
	OG0000 OG0011

NSD - Dizziness postural, mild

Title	Measurements
	OG0000 OG0011

NSD - Dizziness postural, moderate

Title	Measurements
	OG0001 OG0010

NSD - Dizziness postural, severe

Title	Measurements
	OG0000 OG0010

NSD - Dysesthesia, mild

Title	Measurements
	OG0000 OG0010

NSD - Dysesthesia, moderate

Title	Measurements
	OG0001 OG0011

NSD - Dysesthesia, severe

Title	Measurements
	OG0000 OG0010

NSD - Parosmia, mild

Title	Measurements
	OG0002 OG0010

NSD - Parosmia, moderate

Title	Measurements
	OG0000 OG0010

NSD - Parosmia, severe

Title	Measurements
	OG0000 OG0010

NSD - Akathisia, mild

Title	Measurements
	OG0000 OG0010

NSD - Akathisia, moderate

Title	Measurements
	OG0001 OG0010

NSD - Akathisia, severe

Title	Measurements
	OG0000 OG0010

NSD - Anterograde Amnesia, mild

Title	Measurements
	OG0001 OG0010

NSD - Anterograde Amnesia, moderate

Title	Measurements
	OG0000 OG0010

NSD - Anterograde Amnesia, severe

Title	Measurements
	OG0000 OG0010

NSD - Dysarthria, mild

Title	Measurements
	OG0001 OG0010

NSD - Dysarthria, moderate

Title	Measurements
	OG0000 OG0010

NSD - Dysarthria, severe

Title	Measurements
	OG0000 OG0010

NSD - Head discomfort, mild

Title	Measurements
	OG0001 OG0010

NSD - Head discomfort, moderate

Title	Measurements
	OG0000 OG0010

NSD - Head discomfort, severe

Title	Measurements
	OG0000 OG0010

NSD - Hyperesthesia, mild

Title	Measurements
	OG0000 OG0011

NSD - Hyperesthesia, moderate

Title	Measurements
	OG0000 OG0010

NSD - Hyperesthesia, severe

Title	Measurements
	OG0000 OG0010

NSD - Loss of consciousness, mild

Title	Measurements
	OG0000 OG0011

NSD - Loss of consciousness, moderate

Title	Measurements
	OG0000 OG0010

NSD - Loss of consciousness, severe

Title	Measurements
	OG0000 OG0010

NSD - Paraesthesia, mild

Title	Measurements
	OG0000 OG0011

NSD - Paraesthesia, moderate

Title	Measurements
	OG0000 OG0010

NSD - Paraesthesia, severe

Title	Measurements
	OG0000 OG0010

Gastrointestinal Disorders (GID)-Any Event, mild

Title	Measurements
	OG00028 OG00132

GID - Any Event, moderate

Title	Measurements
	OG00015 OG00114

GID - Any Event, severe

Title	Measurements
	OG0001 OG0010

GID - Nausea, mild

Title	Measurements
	OG00012 OG00116

GID - Nausea, moderate

Title	Measurements
	OG0008 OG00110

GID - Nausea, severe

Title	Measurements
	OG0001 OG0010

GID - Diarrhea, mild

Title	Measurements
	OG0006 OG0016

GID - Diarrhea, moderate

Title	Measurements
	OG0003 OG0011

GID - Diarrhea, severe

Title	Measurements
	OG0000 OG0010

GID - Vomiting, mild

Title	Measurements
	OG0004 OG0015

GID - Vomiting, moderate

Title	Measurements
	OG0004 OG0012

GID - Vomiting, severe

Title	Measurements
	OG0000 OG0010

GID - Abdominal Pain upper, mild

Title	Measurements
	OG0000 OG0013

GID - Abdominal Pain upper, moderate

Title	Measurements
	OG0001 OG0012

GID - Abdominal Pain upper, severe

Title	Measurements
	OG0000 OG0010

GID - Stomach Discomfort, mild

Title	Measurements
	OG0002 OG0013

GID - Stomach Discomfort, moderate

Title	Measurements
	OG0001 OG0010

GID - Stomach Discomfort, severe

Title	Measurements
	OG0000 OG0010

GID - Constipation, mild

Title	Measurements
	OG0005 OG0010

GID - Constipation, moderate

Title	Measurements
	OG0000 OG0010

GID - Constipation, severe

Title	Measurements
	OG0000 OG0010

GID - Abdominal Pain, mild

Title	Measurements
	OG0001 OG0013

GID - Abdominal Pain, moderate

Title	Measurements
	OG0000 OG0010

GID - Abdominal Pain, severe

Title	Measurements
	OG0000 OG0010

GID - Stomatitis, mild

Title	Measurements
	OG0001 OG0012

GID - Stomatitis, moderate

Title	Measurements
	OG0000 OG0011

GID - Stomatitis, severe

Title	Measurements
	OG0000 OG0010

GID - Toothache, mild

Title	Measurements
	OG0002 OG0010

GID - Toothache, moderate

Title	Measurements
	OG0001 OG0010

GID - Toothache, severe

Title	Measurements
	OG0000 OG0010

GID - Abdominal Distension, mild

Title	Measurements
	OG0000 OG0012

GID - Abdominal Distension, moderate

Title	Measurements
	OG0000 OG0010

GID - Abdominal Distension, severe

Title	Measurements
	OG0000 OG0010

GID - Gastritis, mild

Title	Measurements
	OG0001 OG0011

GID - Gastritis, moderate

Title	Measurements
	OG0000 OG0010

GID - Gastritis, severe

Title	Measurements
	OG0000 OG0010

GID - Hypoesthesia oral, mild

Title	Measurements
	OG0001 OG0011

GID - Hypoesthesia oral, moderate

Title	Measurements
	OG0000 OG0010

GID - Hypoesthesia oral, severe

Title	Measurements
	OG0000 OG0010

GID - Melaena, mild

Title	Measurements
	OG0001 OG0011

GID - Melaena, moderate

Title	Measurements
	OG0000 OG0010

GID - Melaena, severe

Title	Measurements
	OG0000 OG0010

GID - Abdominal Pain Lower, mild

Title	Measurements
	OG0000 OG0010

GID - Abdominal Pain Lower, moderate

Title	Measurements
	OG0000 OG0011

GID - Abdominal Pain Lower, severe

Title	Measurements
	OG0000 OG0010

GID - Dyspepsia, mild

Title	Measurements
	OG0000 OG0010

GID - Dyspepsia, moderate

Title	Measurements
	OG0001 OG0010

GID - Dyspepsia, severe

Title	Measurements
	OG0000 OG0010

GID - Gingival Swelling, mild

Title	Measurements
	OG0001 OG0010

GID - Gingival Swelling, moderate

Title	Measurements
	OG0000 OG0010

GID - Gingival Swelling, severe

Title	Measurements
	OG0000 OG0010

Infections and Infestations (INF)-Any Event, mild

Title	Measurements
	OG00038 OG00130

INF - Any Event, moderate

Title	Measurements
	OG0003 OG0014

INF - Any Event, severe

Title	Measurements
	OG0000 OG0010

INF - Nasopharyngitis, mild

Title	Measurements
	OG00031 OG00124

INF - Nasopharyngitis, moderate

Title	Measurements
	OG0000 OG0014

INF - Nasopharyngitis, severe

Title	Measurements
	OG0000 OG0010

INF - Gastrointestinal infection, mild

Title	Measurements
	OG0003 OG0013

INF - Gastrointestinal infection, moderate

Title	Measurements
	OG0000 OG0010

INF - Gastrointestinal infection, severe

Title	Measurements
	OG0000 OG0010

INF - Bronchitis acute, mild

Title	Measurements
	OG0000 OG0013

INF - Bronchitis acute, moderate

Title	Measurements
	OG0000 OG0010

INF - Bronchitis acute, severe

Title	Measurements
	OG0000 OG0010

INF - Bronchitis, mild

Title	Measurements
	OG0001 OG0010

INF - Bronchitis, moderate

Title	Measurements
	OG0001 OG0010

INF - Bronchitis, severe

Title	Measurements
	OG0000 OG0010

INF - Gastroenteritis, mild

Title	Measurements
	OG0001 OG0010

INF - Gastroenteritis, moderate

Title	Measurements
	OG0001 OG0010

INF - Gastroenteritis, severe

Title	Measurements
	OG0000 OG0010

INF - Enteritis Infectious, mild

Title	Measurements
	OG0001 OG0010

INF - Enteritis Infectious, moderate

Title	Measurements
	OG0000 OG0010

INF - Enteritis Infectious, severe

Title	Measurements
	OG0000 OG0010

INF - Gastroenteritis viral, mild

Title	Measurements
	OG0000 OG0010

INF - Gastroenteritis viral, moderate

Title	Measurements
	OG0001 OG0010

INF - Gastroenteritis viral, severe

Title	Measurements
	OG0000 OG0010

INF - Otitis Externa, mild

Title	Measurements
	OG0001 OG0010

INF - Otitis Externa, moderate

Title	Measurements
	OG0000 OG0010

INF - Otitis Externa, severe

Title	Measurements
	OG0000 OG0010

INF - Purulence, mild

Title	Measurements
	OG0001 OG0010

INF - Purulence, moderate

Title	Measurements
	OG0000 OG0010

INF - Purulence, severe

Title	Measurements
	OG0000 OG0010

INF - Rhinitis, mild

Title	Measurements
	OG0000 OG0011

INF - Rhinitis, moderate

Title	Measurements
	OG0000 OG0010

INF - Rhinitis, severe

Title	Measurements
	OG0000 OG0010

INF - Vaginal Candidiasis, mild

Title	Measurements
	OG0001 OG0010

INF - Vaginal Candidiasis, moderate

Title	Measurements
	OG0000 OG0010

INF - Vaginal Candidiasis, severe

Title	Measurements
	OG0000 OG0010

Psychiatric Disorders (PsyDO) - Any Event, mild

Title	Measurements
	OG0008 OG00110

PsyDO - Any Event, moderate

Title	Measurements
	OG00013 OG00114

PsyDO - Any Event, severe

Title	Measurements
	OG0007 OG0015

PsyDO - Depression, mild

Title	Measurements
	OG0002 OG0012

PsyDO - Depression, moderate

Title	Measurements
	OG00011 OG0019

PsyDO - Depression, severe

Title	Measurements
	OG0007 OG0013

PsyDO - Insomnia, mild

Title	Measurements
	OG0000 OG0014

PsyDO - Insomnia, moderate

Title	Measurements
	OG0001 OG0011

PsyDO - Insomnia, severe

Title	Measurements
	OG0000 OG0010

PsyDO - Mood altered, mild

Title	Measurements
	OG0003 OG0012

PsyDO - Mood altered, moderate

Title	Measurements
	OG0000 OG0011

PsyDO - Mood altered, severe

Title	Measurements
	OG0000 OG0010

PsyDO - Mania, mild

Title	Measurements
	OG0000 OG0010

PsyDO - Mania, moderate

Title	Measurements
	OG0001 OG0010

PsyDO - Mania, severe

Title	Measurements
	OG0000 OG0011

PsyDO - Anxiety, mild

Title	Measurements
	OG0001 OG0010

PsyDO - Anxiety, moderate

Title	Measurements
	OG0000 OG0010

PsyDO - Anxiety, severe

Title	Measurements
	OG0000 OG0010

PsyDO - Bipolar Disorder, mild

Title	Measurements
	OG0000 OG0010

PsyDO - Bipolar Disorder, moderate

Title	Measurements
	OG0000 OG0010

PsyDO - Bipolar Disorder, severe

Title	Measurements
	OG0000 OG0011

PsyDO - Bruxism, mild

Title	Measurements
	OG0000 OG0011

PsyDO - Bruxism, moderate

Title	Measurements
	OG0000 OG0010

PsyDO - Bruxism, severe

Title	Measurements
	OG0000 OG0010

PsyDO - Delerium, mild

Title	Measurements
	OG0000 OG0011

PsyDO - Delerium, moderate

Title	Measurements
	OG0000 OG0010

PsyDO - Delerium, severe

Title	Measurements
	OG0000 OG0010

PsyDO - Depression suicidal, mild

Title	Measurements
	OG0000 OG0010

PsyDO - Depression suicidal, moderate

Title	Measurements
	OG0000 OG0011

PsyDO - Depression suicidal, severe

Title	Measurements
	OG0000 OG0010

PsyDO - Dysphoria, mild

Title	Measurements
	OG0000 OG0011

PsyDO - Dysphoria, moderate

Title	Measurements
	OG0000 OG0010

PsyDO - Dysphoria, severe

Title	Measurements
	OG0000 OG0010

PsyDO - Early morning awakening, mild

Title	Measurements
	OG0000 OG0010

PsyDO - Early morning awakening, moderate

Title	Measurements
	OG0000 OG0011

PsyDO - Early morning awakening, severe

Title	Measurements
	OG0000 OG0010

PsyDO - Hallucination, mild

Title	Measurements
	OG0000 OG0011

PsyDO - Hallucination, moderate

Title	Measurements
	OG0000 OG0010

PsyDO - Hallucination, severe

Title	Measurements
	OG0000 OG0010

PsyDO - Hypomania, mild

Title	Measurements
	OG0001 OG0010

PsyDO - Hypomania, moderate

Title	Measurements
	OG0000 OG0010

PsyDO - Hypomania, severe

Title	Measurements
	OG0000 OG0010

PsyDO - Intentional self-injury, mild

Title	Measurements
	OG0001 OG0010

PsyDO - Intentional self-injury, moderate

Title	Measurements
	OG0000 OG0010

PsyDO - Intentional self-injury, severe

Title	Measurements
	OG0000 OG0010

PsyDO - Libido decreased, mild

Title	Measurements
	OG0001 OG0010

PsyDO - Libido decreased, moderate

Title	Measurements
	OG0000 OG0010

PsyDO - Libido decreased, severe

Title	Measurements
	OG0000 OG0010

PsyDO - Nightmare, mild

Title	Measurements
	OG0000 OG0010

PsyDO - Nightmare, moderate

Title	Measurements
	OG0000 OG0011

PsyDO - Nightmare, severe

Title	Measurements
	OG0000 OG0010

General Disorders (GD) - Any Event, mild

Title	Measurements
	OG00010 OG00116

GD - Any Event, moderate

Title	Measurements
	OG0005 OG0015

GD - Any Event, severe

Title	Measurements
	OG0000 OG0010

GD - Drug Withdrawal Syndrome, mild

Title	Measurements
	OG0002 OG0016

GD - Drug Withdrawal Syndrome, moderate

Title	Measurements
	OG0002 OG0013

GD - Drug Withdrawal Syndrome, severe

Title	Measurements
	OG0000 OG0010

GD - Thirst, mild

Title	Measurements
	OG0004 OG0019

GD - Thirst, moderate

Title	Measurements
	OG0000 OG0010

GD - Thirst, severe

Title	Measurements
	OG0000 OG0010

GD - Malaise, mild

Title	Measurements
	OG0001 OG0011

GD - Malaise, moderate

Title	Measurements
	OG0002 OG0010

GD - Malaise, severe

Title	Measurements
	OG0000 OG0010

GD - Feeling abnormal, mild

Title	Measurements
	OG0000 OG0011

GD - Feeling abnormal, moderate

Title	Measurements
	OG0000 OG0011

GD - Feeling abnormal, severe

Title	Measurements
	OG0000 OG0010

GD - Irritability, mild

Title	Measurements
	OG0000 OG0010

GD - Irritability, moderate

Title	Measurements
	OG0001 OG0011

GD - Irritability, severe

Title	Measurements
	OG0000 OG0010

GD - Chills, mild

Title	Measurements
	OG0001 OG0010

GD - Chills, moderate

Title	Measurements
	OG0000 OG0010

GD - Chills, severe

Title	Measurements
	OG0000 OG0010

GD - Edema, mild

Title	Measurements
	OG0001 OG0010

GD - Edema, moderate

Title	Measurements
	OG0000 OG0010

GD - Edema, severe

Title	Measurements
	OG0000 OG0010

GD - Edema peripheral, mild

Title	Measurements
	OG0001 OG0010

GD - Edema peripheral, moderate

Title	Measurements
	OG0000 OG0010

GD - Edema peripheral, severe

Title	Measurements
	OG0000 OG0010

GD - Pain, mild

Title	Measurements
	OG0001 OG0010

GD - Pain, moderate

Title	Measurements
	OG0000 OG0010

GD - Pain, severe

Title	Measurements
	OG0000 OG0010

Skin & tissue disorders (SDO) - Any Event, mild

Title	Measurements
	OG0006 OG0018

SDO - Any Event, moderate

Title	Measurements
	OG0001 OG0016

SDO - Any Event, severe

Title	Measurements
	OG0000 OG0011

SDO - Urticaria, mild

Title	Measurements
	OG0000 OG0011

SDO - Urticaria, moderate

Title	Measurements
	OG0000 OG0014

SDO - Urticaria, severe

Title	Measurements
	OG0000 OG0010

SDO - Rash, mild

Title	Measurements
	OG0001 OG0012

SDO - Rash, moderate

Title	Measurements
	OG0000 OG0011

SDO - Rash, severe

Title	Measurements
	OG0000 OG0010

SDO - Eczema, mild

Title	Measurements
	OG0001 OG0011

SDO - Eczema, moderate

Title	Measurements
	OG0000 OG0010

SDO - Eczema, severe

Title	Measurements
	OG0000 OG0010

SDO - Hyperhidrosis, mild

Title	Measurements
	OG0002 OG0010

SDO - Hyperhidrosis, moderate

Title	Measurements
	OG0000 OG0010

SDO - Hyperhidrosis, severe

Title	Measurements
	OG0000 OG0010

SDO - Hypoesthesia facial, mild

Title	Measurements
	OG0000 OG0012

SDO - Hypoesthesia facial, moderate

Title	Measurements
	OG0000 OG0010

SDO - Hypoesthesia facial, severe

Title	Measurements
	OG0000 OG0010

SDO - Pruritus generalised, mild

Title	Measurements
	OG0000 OG0011

SDO - Pruritus generalised, moderate

Title	Measurements
	OG0000 OG0011

SDO - Pruritus generalised, severe

Title	Measurements
	OG0000 OG0010

SDO - Alopecia, mild

Title	Measurements
	OG0000 OG0010

SDO - Alopecia, moderate

Title	Measurements
	OG0000 OG0011

SDO - Alopecia, severe

Title	Measurements
	OG0000 OG0010

SDO - Alopecia areata, mild

Title	Measurements
	OG0000 OG0011

SDO - Alopecia areata, moderate

Title	Measurements
	OG0000 OG0010

SDO - Alopecia areata, severe

Title	Measurements
	OG0000 OG0010

SDO - Dermatitis Contact, mild

Title	Measurements
	OG0000 OG0010

SDO - Dermatitis Contact, moderate

Title	Measurements
	OG0001 OG0010

SDO - Dermatitis Contact, severe

Title	Measurements
	OG0000 OG0010

SDO - Erythema, mild

Title	Measurements
	OG0001 OG0010

SDO - Erythema, moderate

Title	Measurements
	OG0000 OG0010

SDO - Erythema, severe

Title	Measurements
	OG0000 OG0010

SDO - Hemorrhage subcutaneous, mild

Title	Measurements
	OG0000 OG0010

SDO - Hemorrhage subcutaneous, moderate

Title	Measurements
	OG0000 OG0010

SDO - Hemorrhage subcutaneous, severe

Title	Measurements
	OG0000 OG0011

SDO - Hyperkeratosis, mild

Title	Measurements
	OG0000 OG0011

SDO - Hyperkeratosis, moderate

Title	Measurements
	OG0000 OG0010

SDO - Hyperkeratosis, severe

Title	Measurements
	OG0000 OG0010

SDO - Pigmentation disorder, mild

Title	Measurements
	OG0001 OG0010

SDO - Pigmentation disorder, moderate

Title	Measurements
	OG0000 OG0010

SDO - Pigmentation disorder, severe

Title	Measurements
	OG0000 OG0010

SDO - Sweat Gland Disorder, mild

Title	Measurements
	OG0000 OG0011

SDO - Sweat Gland Disorder, moderate

Title	Measurements
	OG0000 OG0010

SDO - Sweat Gland Disorder, severe

Title	Measurements
	OG0000 OG0010

Investigations (INV) - Any Event, mild

Title	Measurements
	OG0005 OG00110

INV - Any Event, moderate

Title	Measurements
	OG0001 OG0012

INV - Any Event, severe

Title	Measurements
	OG0000 OG0010

INV - Alanine Aminotransferase increased, mild

Title	Measurements
	OG0003 OG0014

INV - Alanine Aminotransferase increased, moderate

Title	Measurements
	OG0000 OG0010

INV - Alanine Aminotransferase increased, severe

Title	Measurements
	OG0000 OG0010

INV - Weight decreased, mild

Title	Measurements
	OG0000 OG0013

INV - Weight decreased, moderate

Title	Measurements
	OG0000 OG0010

INV - Weight decreased, severe

Title	Measurements
	OG0000 OG0010

INV - Aspartate Aminotransferase increased, mild

Title	Measurements
	OG0000 OG0012

INV-Aspartate Aminotransferase increased, moderate

Title	Measurements
	OG0000 OG0010

INV - Aspartate Aminotransferase increased, severe

Title	Measurements
	OG0000 OG0010

INV - Blood Bilirubin increased, mild

Title	Measurements
	OG0001 OG0011

INV - Blood Bilirubin increased, moderate

Title	Measurements
	OG0000 OG0010

INV - Blood Bilirubin increased, severe

Title	Measurements
	OG0000 OG0010

INV - Glucose urine present, mild

Title	Measurements
	OG0000 OG0011

INV - Glucose urine present, moderate

Title	Measurements
	OG0000 OG0011

INV - Glucose urine present, severe

Title	Measurements
	OG0000 OG0010

INV - Protein urine present, mild

Title	Measurements
	OG0000 OG0012

INV - Protein urine present, moderate

Title	Measurements
	OG0000 OG0010

INV - Protein urine present, severe

Title	Measurements
	OG0000 OG0010

INV - White Blood Cell Count decreased, mild

Title	Measurements
	OG0000 OG0011

INV - White Blood Cell Count decreased, moderate

Title	Measurements
	OG0000 OG0011

INV - White Blood Cell Count decreased, severe

Title	Measurements
	OG0000 OG0010

INV - Blood pressure decreased, mild

Title	Measurements
	OG0000 OG0010

INV - Blood pressure decreased, moderate

Title	Measurements
	OG0001 OG0010

INV - Blood pressure decreased, severe

Title	Measurements
	OG0000 OG0010

INV - Electrocardiogram T wave inversion, mild

Title	Measurements
	OG0001 OG0010

INV - Electrocardiogram T wave inversion, moderate

Title	Measurements
	OG0000 OG0010

INV - Electrocardiogram T wave inversion, severe

Title	Measurements
	OG0000 OG0010

INV - Hematocrit decreased, mild

Title	Measurements
	OG0000 OG0011

INV - Hematocrit decreased, moderate

Title	Measurements
	OG0000 OG0010

INV - Hematocrit decreased, severe

Title	Measurements
	OG0000 OG0010

INV - Hemoglobin decreased, mild

Title	Measurements
	OG0000 OG0011

INV - Hemoglobin decreased, moderate

Title	Measurements
	OG0000 OG0010

INV - Hemoglobin decreased, severe

Title	Measurements
	OG0000 OG0010

INV - Red Blood Cell Count decreased, mild

Title	Measurements
	OG0000 OG0011

INV - Red Blood Cell Count decreased, moderate

Title	Measurements
	OG0000 OG0010

INV - Red Blood Cell Count decreased, severe

Title	Measurements
	OG0000 OG0010

Musculoskeletal Disorders (MD) - Any Event, mild

Title	Measurements
	OG0009 OG0016

MD - Any Event, moderate

Title	Measurements
	OG0000 OG0012

MD - Any Event, severe

Title	Measurements
	OG0000 OG0010

MD - Back Pain, mild

Title	Measurements
	OG0001 OG0011

MD - Back Pain, moderate

Title	Measurements
	OG0000 OG0012

MD - Back Pain, severe

Title	Measurements
	OG0000 OG0010

MD - Musculoskeletal stiffness, mild

Title	Measurements
	OG0003 OG0011

MD - Musculoskeletal stiffness, moderate

Title	Measurements
	OG0000 OG0010

MD - Musculoskeletal stiffness, severe

Title	Measurements
	OG0000 OG0010

MD - Myalgia, mild

Title	Measurements
	OG0002 OG0011

MD - Myalgia, moderate

Title	Measurements
	OG0000 OG0010

MD - Myalgia, severe

Title	Measurements
	OG0000 OG0010

MD - Neck Pain, mild

Title	Measurements
	OG0000 OG0012

MD - Neck Pain, moderate

Title	Measurements
	OG0000 OG0010

MD - Neck Pain, severe

Title	Measurements
	OG0000 OG0010

MD - Pain in extremity, mild

Title	Measurements
	OG0002 OG0010

MD - Pain in extremity, moderate

Title	Measurements
	OG0000 OG0010

MD - Pain in extremity, severe

Title	Measurements
	OG0000 OG0010

MD - Arthralgia, mild

Title	Measurements
	OG0000 OG0011

MD - Arthralgia, moderate

Title	Measurements
	OG0000 OG0010

MD - Arthralgia, severe

Title	Measurements
	OG0000 OG0010

MD - Fasciitis, mild

Title	Measurements
	OG0001 OG0010

MD - Fasciitis, moderate

Title	Measurements
	OG0000 OG0010

MD - Fasciitis, severe

Title	Measurements
	OG0000 OG0010

Respiratory Disorders (RTM) - Any Event, mild

Title	Measurements
	OG0004 OG0016

RTM -Any Event, moderate

Title	Measurements
	OG0000 OG0013

RTM -Any Event, severe

Title	Measurements
	OG0000 OG0010

RTM - Upper respiratory Tract inflammation, mild

Title	Measurements
	OG0003 OG0013

RTM-Upp. respiratory Tract inflammation, moderate

Title	Measurements
	OG0000 OG0011

RTM-Upp. respiratory Tract inflammation, severe

Title	Measurements
	OG0000 OG0010

RTM - Asthma, mild

Title	Measurements
	OG0000 OG0012

RTM - Asthma, moderate

Title	Measurements
	OG0000 OG0011

RTM - Asthma, severe

Title	Measurements
	OG0000 OG0010

RTM - Cough, mild

Title	Measurements
	OG0000 OG0011

RTM - Cough, moderate

Title	Measurements
	OG0000 OG0011

RTM - Cough, severe

Title	Measurements
	OG0000 OG0010

RTM - Pharyngolaryngeal Pain, mild

Title	Measurements
	OG0001 OG0010

RTM - Pharyngolaryngeal Pain, moderate

Title	Measurements
	OG0000 OG0010

RTM - Pharyngolaryngeal Pain, severe

Title	Measurements
	OG0000 OG0010

Injury and complications (IPPC) - Any Event, mild

Title	Measurements
	OG0002 OG0012

IPPC - Any Event, moderate

Title	Measurements
	OG0001 OG0013

IPPC - Any Event, severe

Title	Measurements
	OG0000 OG0010

IPPC - Contusion, mild

Title	Measurements
	OG0000 OG0012

IPPC - Contusion, moderate

Title	Measurements
	OG0000 OG0010

IPPC - Contusion, severe

Title	Measurements
	OG0000 OG0010

IPPC - Intentional Overdose, mild

Title	Measurements
	OG0001 OG0010

IPPC - Intentional Overdose, moderate

Title	Measurements
	OG0000 OG0011

IPPC - Intentional Overdose, severe

Title	Measurements
	OG0000 OG0010

IPPC - Head Injury, mild

Title	Measurements
	OG0000 OG0010

IPPC - Head Injury, moderate

Title	Measurements
	OG0000 OG0011

IPPC - Head Injury, severe

Title	Measurements
	OG0000 OG0010

IPPC - Joint sprain, mild

Title	Measurements
	OG0000 OG0011

IPPC - Joint sprain, moderate

Title	Measurements
	OG0000 OG0010

IPPC - Joint sprain, severe

Title	Measurements
	OG0000 OG0010

IPPC - Rib fracture, mild

Title	Measurements
	OG0000 OG0010

IPPC - Rib fracture, moderate

Title	Measurements
	OG0001 OG0010

IPPC - Rib fracture, severe

Title	Measurements
	OG0000 OG0010

IPPC - Thermal Burn, mild

Title	Measurements
	OG0000 OG0010

IPPC - Thermal Burn, moderate

Title	Measurements
	OG0000 OG0011

IPPC - Thermal Burn, severe

Title	Measurements
	OG0000 OG0010

IPPC - Wound, mild

Title	Measurements
	OG0001 OG0010

IPPC - Wound, moderate

Title	Measurements
	OG0000 OG0010

IPPC - Wound, severe

Title	Measurements
	OG0000 OG0010

Ear Disorders (ED) - Any Event, mild

Title	Measurements
	OG0003 OG0012

ED - Any Event, moderate

Title	Measurements
	OG0000 OG0010

ED - Any Event, severe

Title	Measurements
	OG0000 OG0010

ED - Tinnitus, mild

Title	Measurements
	OG0002 OG0012

ED - Tinnitus, moderate

Title	Measurements
	OG0000 OG0010

ED - Tinnitus, severe

Title	Measurements
	OG0000 OG0010

ED - Ear Discomfort, mild

Title	Measurements
	OG0001 OG0010

ED - Ear Discomfort, moderate

Title	Measurements
	OG0000 OG0010

ED - Ear Discomfort, severe

Title	Measurements
	OG0000 OG0010

Eye Disorders (EyeDO) - Any Event, mild

Title	Measurements
	OG0000 OG0011

EyeDO - Any Event, moderate

Title	Measurements
	OG0000 OG0013

EyeDO - Any Event, severe

Title	Measurements
	OG0000 OG0010

EyeDO - Chalazion, mild

Title	Measurements
	OG0000 OG0010

EyeDO - Chalazion, moderate

Title	Measurements
	OG0000 OG0012

EyeDO - Chalazion, severe

Title	Measurements
	OG0000 OG0010

EyeDO - Abnormal sensations in eye, mild

Title	Measurements
	OG0000 OG0010

EyeDO - Abnormal sensations in eye, moderate

Title	Measurements
	OG0000 OG0011

EyeDO - Abnormal sensations in eye, severe

Title	Measurements
	OG0000 OG0010

EyeDO - Conjunctival haemorrhage, mild

Title	Measurements
	OG0000 OG0011

EyeDO - Conjunctival haemorrhage, moderate

Title	Measurements
	OG0000 OG0010

EyeDO - Conjunctival haemorrhage, severe

Title	Measurements
	OG0000 OG0010

Metabolism Disorders (MetDO) - Any Event, mild

Title	Measurements
	OG0002 OG0011

MetDO - Any Event, moderate

Title	Measurements
	OG0001 OG0010

MetDO - Any Event, severe

Title	Measurements
	OG0000 OG0010

MetDO - Anorexia, mild

Title	Measurements
	OG0000 OG0011

MetDO - Anorexia, moderate

Title	Measurements
	OG0001 OG0010

MetDO - Anorexia, severe

Title	Measurements
	OG0000 OG0010

MetDO - Dehydration, mild

Title	Measurements
	OG0002 OG0010

MetDO - Dehydration, moderate

Title	Measurements
	OG0000 OG0010

MetDO - Dehydration, severe

Title	Measurements
	OG0000 OG0010

MetDO - Hyperlipidemia, mild

Title	Measurements
	OG0001 OG0010

MetDO - Hyperlipidemia, moderate

Title	Measurements
	OG0000 OG0010

MetDO - Hyperlipidemia, severe

Title	Measurements
	OG0000 OG0010

MetDO - Hypovitaminosis, mild

Title	Measurements
	OG0001 OG0010

MetDO - Hypovitaminosis, moderate

Title	Measurements
	OG0000 OG0010

MetDO - Hypovitaminosis, severe

Title	Measurements
	OG0000 OG0010

Vascular Disorders (VD) - Any Event, mild

Title	Measurements
	OG0002 OG0012

VD - Any Event, moderate

Title	Measurements
	OG0000 OG0010

VD - Any Event, severe

Title	Measurements
	OG0000 OG0010

VD - Hot Flush, mild

Title	Measurements
	OG0001 OG0012

VD - Hot Flush, moderate

Title	Measurements
	OG0000 OG0010

VD - Hot Flush, severe

Title	Measurements
	OG0000 OG0010

VD - Hypertension, mild

Title	Measurements
	OG0001 OG0010

VD - Hypertension, moderate

Title	Measurements
	OG0000 OG0010

VD - Hypertension, severe

Title	Measurements
	OG0000 OG0010

Blood & Lymph Disorders (BLD) - Any Event, mild

Title	Measurements
	OG0000 OG0012

BLD - Any Event, moderate

Title	Measurements
	OG0000 OG0011

BLD - Any Event, severe

Title	Measurements
	OG0000 OG0010

BLD - Anemia, mild

Title	Measurements
	OG0000 OG0011

BLD - Anemia, moderate

Title	Measurements
	OG0000 OG0011

BLD - Anemia, severe

Title	Measurements
	OG0000 OG0010

BLD - Lymphadenopathy, mild

Title	Measurements
	OG0000 OG0011

BLD - Lymphadenopathy, moderate

Title	Measurements
	OG0000 OG0010

BLD - Lymphadenopathy, severe

Title	Measurements
	OG0000 OG0010

Hepatobiliary disorders (HD) - Any Event, mild

Title	Measurements
	OG0001 OG0011

HD - Any Event, moderate

Title	Measurements
	OG0000 OG0011

HD - Any Event, severe

Title	Measurements
	OG0000 OG0010

HD - Hepatic Function abnormal, mild

Title	Measurements
	OG0001 OG0011

HD - Hepatic Function abnormal, moderate

Title	Measurements
	OG0000 OG0011

HD - Hepatic Function abnormal, severe

Title	Measurements
	OG0000 OG0010

Reproductive Disorders (RBD) - Any Event, mild

Title	Measurements
	OG0000 OG0011

RBD - Any Event, moderate

Title	Measurements
	OG0000 OG0011

RBD - Any Event, severe

Title	Measurements
	OG0000 OG0011

RBD - Galactorrhea, mild

Title	Measurements
	OG0000 OG0010

RBD - Galactorrhea, moderate

Title	Measurements
	OG0000 OG0011

RBD - Galactorrhea, severe

Title	Measurements
	OG0000 OG0010

RBD - Menometrorrhagia, mild

Title	Measurements
	OG0000 OG0011

RBD - Menometrorrhagia, moderate

Title	Measurements
	OG0000 OG0010

RBD - Menometrorrhagia, severe

Title	Measurements
	OG0000 OG0010

RBD - Premenstrual Syndrome, mild

Title	Measurements
	OG0000 OG0010

RBD - Premenstrual Syndrome, moderate

Title	Measurements
	OG0000 OG0010

RBD - Premenstrual Syndrome, severe

Title	Measurements
	OG0000 OG0011

Cardiac Disorders (CD) - Any Event, mild

Title	Measurements
	OG0001 OG0011

CD - Any Event, moderate

Title	Measurements
	OG0000 OG0010

CD - Any Event, severe

Title	Measurements
	OG0000 OG0010

CD - Palpitations, mild

Title	Measurements
	OG0001 OG0011

CD - Palpitations, moderate

Title	Measurements
	OG0000 OG0010

CD - Palpitations, severe

Title	Measurements
	OG0000 OG0010

Renal & Urinary Disorders (RUD) - Any Event, mild

Title	Measurements
	OG0000 OG0012

RUD - Any Event, moderate

Title	Measurements
	OG0000 OG0010

RUD - Any Event, severe

Title	Measurements
	OG0000 OG0010

RUD - Dysuria, mild

Title	Measurements
	OG0000 OG0011

RUD - Dysuria, moderate

Title	Measurements
	OG0000 OG0010

RUD - Dysuria, severe

Title	Measurements
	OG0000 OG0010

RUD - Pollakiuria, mild

Title	Measurements
	OG0000 OG0011

RUD - Pollakiuria, moderate

Title	Measurements
	OG0000 OG0010

RUD - Pollakiuria, severe

Title	Measurements
	OG0000 OG0010

Endocrine Disorders (ENDO) - Any Event, mild

Title	Measurements
	OG0000 OG0011

ENDO - Any Event, moderate

Title	Measurements
	OG0000 OG0010

ENDO - Any Event, severe

Title	Measurements
	OG0000 OG0010

ENDO - Hyperprolactinaemia, mild

Title	Measurements
	OG0000 OG0011

ENDO - Hyperprolactinaemia, moderate

Title	Measurements
	OG0000 OG0010

ENDO - Hyperprolactinaemia, severe

Title	Measurements
	OG0000 OG0010

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.			0		124	159
EG001	Bupropion SR	Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.			5		125	166

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Depressed level of Consciousness	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected159 at risk EG0012 affected166 at risk
Convulsion	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected159 at risk EG0011 affected166 at risk
Bipolar Disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected159 at risk EG0011 affected166 at risk
Mania	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected159 at risk EG0011 affected166 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected159 at risk EG0011 affected166 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00031 affected159 at risk EG00128 affected166 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00021 affected159 at risk EG00126 affected166 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG00020 affected159 at risk EG00114 affected166 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG00016 affected159 at risk EG00116 affected166 at risk
Somnolence	Psychiatric disorders	MedDRA	Systematic Assessment	EG00010 affected159 at risk EG0018 affected166 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0009 affected159 at risk EG00115 affected166 at risk
Diarrhea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0009 affected159 at risk EG0017 affected166 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0008 affected159 at risk EG0017 affected166 at risk
Drug Withdrawal syndrome	General disorders	MedDRA	Systematic Assessment	EG0004 affected159 at risk EG0019 affected166 at risk
Thirst	General disorders	MedDRA	Systematic Assessment	EG0004 affected159 at risk EG0019 affected166 at risk

ID	Term
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms
D001519	Behavior

ID	Title	Description
BG000	Placebo	Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
BG001	Bupropion SR	Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
BG002	Total	Total of all reporting groups