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SECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL PRACTICE
This study will be conducted under the central registration system until the number of subjects who meet the conditions for registration reaches the target number of subjects. 12 weeks from the start date. The patients who completed the 12-week treatment with this product will be observed up until Week 52.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| venlafaxine | Patients with no experience of using time Effexor(venlafaxine) who will be administered time Effexor(venlafaxine)for the first |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| venlafaxine | Drug | The usual adult starting dosage for oral use is 37.5 mg of venlafaxine once daily, which is increased to 75 mg once daily after a meal from 1 week later. The dose may be adjusted within a range not exceeding 225 mg/day according to the patient's age and symptoms. However, the dose should be increased by 75 mg/day at intervals of not less than 1 week. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Drug Reactions | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Effexor in a participant who received Effexor. A serious ADR was a ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Effexor was assessed by the physician. | 12 weeks from the start date (up until 52 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Scores at Pre-specified Evaluation Points | HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAM-D17 are rated on a scale of 0 to 2 (8 items) or from 0 to 4 (9 items), and the total score ranges from 0 to 52, higher scores indicating more severity. Change from baseline: mean score at observation minus mean score at baseline. Evaluation was performed at Week 4, 8, 12, 16, 24, 36, and 52. |
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Inclusion Criteria:
Exclusion Criteria:
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The patients who meet the inclusion criteria and who were registered to this study within 14 days including the start date of treatment with this product will be subjects for this study
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) | Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 1408 participants were enrolled in this study. Of the 1396 participants who completed the study, 62 participants were excluded from the safety analysis set due to the following reasons: no adverse event information (no visit after first day of treatment)(57 participants), no drug administration (3 participants), protocol violation (2 participants).
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| ID | Title | Description |
|---|---|---|
| BG000 | EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) | Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 Adverse Drug Reactions | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Effexor in a participant who received Effexor. A serious ADR was a ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Effexor was assessed by the physician. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Effexor at least once. | Posted | Number | Participants | 12 weeks from the start date (up until 52 weeks) |
|
12 weeks from the start date (up until 52 weeks)
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) | Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alcoholic pancreatitis | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2018 | Apr 29, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 11, 2020 | Apr 29, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000069470 | Venlafaxine Hydrochloride |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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|
|
| 12 weeks from the start date ( up until 52 weeks) |
| Change From Baseline in the Montgomery - Asberg Depression Rating Scale (MADRS) Total Scores at Pre-specified Evaluation Points | MADRS is a clinician-administered rating scale that assesses the overall severity of depressive symptoms. The MADRS had a 10-item checklist (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items are scored from 0 to 6, and the total score ranges from 0 to 60, higher scores indicating more severity. Change from baseline: mean score at observation minus mean score at baseline. Evaluation was performed at Week 4, 8, 12, 16, 24, 36, and 52. | 12 weeks from the start date ( up until 52 weeks) |
| Clinical Global Impressions-Severity | CGI-S is a 7-point clinician-administered rating scale that assesses overall severity of the current illness state. The score ranges from 1 to 7, higher scores indicating more affected: "1: normal, not at all ill," "2: borderline mentally ill," "3: mildly ill," "4: moderately ill," "5: markedly ill," "6: severely ill," or "7: among the most extremely ill patients." Evaluation was performed at Week 4, 8, 12, 16, 24, 36, and 52. | 12 weeks from the start date (up until 52 weeks) |
| Changes in the Clinical Global Impressions-Improvement | CGI-I is a 7-point clinician-administered rating scale that assesses overall improvement of the disease/condition. The score ranges from 1 to 7, higher scores indicating more affected: was assessed as "1: markedly improved," "2: moderately improved," "3: mildly improved," "4: no change," "5: slightly worsened," "6: worsened," or "7: severely worsened." Evaluation was performed at Week 4, 8, 12, 16, 24, 36, and 52. | 12 weeks from the start date (up until 52 weeks) |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Secondary | Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Scores at Pre-specified Evaluation Points | HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAM-D17 are rated on a scale of 0 to 2 (8 items) or from 0 to 4 (9 items), and the total score ranges from 0 to 52, higher scores indicating more severity. Change from baseline: mean score at observation minus mean score at baseline. Evaluation was performed at Week 4, 8, 12, 16, 24, 36, and 52. | The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Of the participants included in the efficacy analysis set (n=1312), 1259 participants had available data at baseline. | Posted | Mean | Standard Deviation | Unit on a scale | 12 weeks from the start date ( up until 52 weeks) |
|
|
|
| Secondary | Change From Baseline in the Montgomery - Asberg Depression Rating Scale (MADRS) Total Scores at Pre-specified Evaluation Points | MADRS is a clinician-administered rating scale that assesses the overall severity of depressive symptoms. The MADRS had a 10-item checklist (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items are scored from 0 to 6, and the total score ranges from 0 to 60, higher scores indicating more severity. Change from baseline: mean score at observation minus mean score at baseline. Evaluation was performed at Week 4, 8, 12, 16, 24, 36, and 52. | The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Of the participants included in the efficacy analysis set (n=1312), 902 participants had available data at baseline. | Posted | Mean | Standard Deviation | Unit on a scale | 12 weeks from the start date ( up until 52 weeks) |
|
|
|
| Secondary | Clinical Global Impressions-Severity | CGI-S is a 7-point clinician-administered rating scale that assesses overall severity of the current illness state. The score ranges from 1 to 7, higher scores indicating more affected: "1: normal, not at all ill," "2: borderline mentally ill," "3: mildly ill," "4: moderately ill," "5: markedly ill," "6: severely ill," or "7: among the most extremely ill patients." Evaluation was performed at Week 4, 8, 12, 16, 24, 36, and 52. | The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Of the participants included in the efficacy analysis set (n=1312), a cross tabulation of the patients with available baseline CGI-S scores by CGI-S scores Week 12 and Week 52 is described. | Posted | Number | Participants | 12 weeks from the start date (up until 52 weeks) |
|
|
|
| Secondary | Changes in the Clinical Global Impressions-Improvement | CGI-I is a 7-point clinician-administered rating scale that assesses overall improvement of the disease/condition. The score ranges from 1 to 7, higher scores indicating more affected: was assessed as "1: markedly improved," "2: moderately improved," "3: mildly improved," "4: no change," "5: slightly worsened," "6: worsened," or "7: severely worsened." Evaluation was performed at Week 4, 8, 12, 16, 24, 36, and 52. | The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Of the participants included in the efficacy analysis set (n=1312), those who had available data at Week 12 and 52 were evaluated. | Posted | Number | Participants | 12 weeks from the start date (up until 52 weeks) |
|
|
|
| 0 |
| 1,334 |
| 20 |
| 1,334 |
| 495 |
| 1,334 |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
|
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | Non-systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Depressive symptom | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Hypomania | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Mania | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Withdrawal syndrome | General disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Hyperphagia | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | Non-systematic Assessment |
|
| Anger | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Hallucination, auditory | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Hypomania | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Initial insomnia | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Intentional self-injury | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Mania | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Middle insomnia | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Ejaculation disorder | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Organic Chemicals |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008055 | Lipids |
|
| Week 12 (n=667) |
|
|
| Week 16 (n=233) |
|
|
| Week 24 (n=124) |
|
|
| Week 36 (n=116) |
|
|
| Week 52 (n=527) |
|
|
|
| Week 12 (n=501) |
|
|
| Week 16 (n=173) |
|
|
| Week 24 (n=93) |
|
|
| Week 36 (n=81) |
|
|
| Week 52 (n=414) |
|
|
| Week 12 2: Borderline mentally ill |
|
| Week 12 3: Mildly ill |
|
| Week 12 4: Moderately ill |
|
| Week 12 5: Markedly ill |
|
| Week 12 6: Severely ill |
|
| Week 12 7: Among the most extremely ill patients |
|
| Week 52 1: Normal, not at all ill |
|
| Week 52 2: Borderline mentally ill |
|
| Week 52 3: Mildly ill |
|
| Week 52 4: Moderately ill |
|
| Week 52 5: Markedly ill |
|
| Week 52 6: Severely ill |
|
| Week 52 7: Among the most extremely ill patients |
|
| 3: Mildly improved |
|
| 4: No change |
|
| 5: Slightly worsened |
|
| 6: Worsened |
|
| 7: Severely worsened |
|